Where to apply for a UDI code and what is a uDI code?

Steps to apply for a UDI code (UDI public platform).

1.Choose the right company's code issuing agency.

2.Make a UDI declaration.

3.Open it. Register for free, complete the enterprise information authentication and obtain the enterprise code;

4.After registration, according to the actual situation of the enterprise, select the service version (basic edition, advanced edition) to pay the fee;

5.Login. Complete the registration in the office hall of the Food and Drug Administration;

6.Go back to the UDI public platform, obtain DI codes in batches and apply to the NMPA with one click;

7.Generate PI codes in batches and dock with label printing equipment;

8.UDI label design and label attaching.

Unique Device Identification (UDI) is the identity given to a medical device throughout its life cycle, and it is its unique "ID card" in the product chain. The global adoption of a unified and standard UDI is conducive to improving the transparency and operational efficiency of the ** chain; Conducive to reducing operating costs; It is conducive to the realization of information sharing and exchange; It is conducive to the monitoring of adverse events and the recall of problematic products, improving the quality of medical services and ensuring patient safety. Yibo Testing can help enterprises apply for UDI code.

UDI (Unique Devive Identifion) is a kind of medical device product or packaging, composed of numbers, letters or symbols, which is used to uniquely identify medical devices.

The complete UDI system consists of three parts: unique identification, data carrier and database. The unique identifier is the electronic ID card of the medical device product; The data carrier is the data medium that stores or transmits the unique identification of the medical device; The database is a database that stores the product identification and management information of the unique identification of medical devices.

UDI is a code that consists of numbers or letters. It consists of a Device Identification Number (DI) and a Production Identification Number (PI).

Among them, the device identification code (DI) is static information, which is the identification of the medical device product in the first chain, and can be used as a "keyword" to enter the database to query the basic traceability information of the product. The production identification number (PI) is dynamic information, which includes the serial number, batch number, production date and expiration date of the medical device product, etc., and is the dynamic additional information of the medical device product, which is used in conjunction with the device identification number (DI), which refers to a specific medical device product.

IDI Application Process.

Step 1: Apply and design UDI

Apply for a product code (DI) from the issuing authority

Compile UDI (composed of PI+DI, DI applies to the key random call issuing authority, and the PI manufacturer prepares it itself in accordance with the coding rules).

UDI runs (imprints UDI on medical devices).

Step 2: Declare and maintain UDI

Collect the information required by GUDID (Dun & Bradstreet code, GMDN code).

Apply for a gudid

Data submitted gudid

UDI (Unique Device Identification), also known as the unique identification of medical devices, is a string of symbols, numbers or letters, which are generally attached to medical device products and packaging. It is the most important part of the unique identification system of medical devices, which is globally unique and can be used for the accurate identification of medical device products, which is convenient for supervision and traceability, so it is also known as the "digital ID" of medical device products.

UDI exists in the entire life cycle of the production, circulation and use of medical device products, and is the basis for accurate identification of medical device information.

Its implementation will reduce barriers to under-identification of medical devices in the market, quickly and accurately identify critical information about the safety and effectiveness of the device, and reduce the resulting medical errors.

At the same time, the UDI system can improve the quality of adverse event reporting of medical devices, more effectively identify problems in the product band family, and recall problem devices more quickly to ensure patient safety.

UDI (unique device identification), also known as the unique identification of medical devices, is a string of symbols, numbers or letters, which is generally attached to the simple products and packaging of medical devices. It is the most important part of the unique identification system of medical devices, which is globally unique and can be used for accurate identification of medical device products, which is convenient for supervision and traceability.

1. UDI is composed of numbers or letters**. It consists of a Device Identification Number (DI) and a Production Identification Number (PI).

Second, the UDI number application is relatively simple and easy, you can operate the application on the UDI public platform with the unique identification of medical devices, and you can complete all the operations of the UDI code application within a few minutes.

3. UDI application process.

1. Fill in the basic information of the product identification, the basic information of the product and the production identification information, and save and obtain the DI logo of the product;

2. Choose to fill in the DI mark and fill it in the database of the Food and Drug Administration with one click;

3. Select the product that needs to generate PI, fill in the production dynamic information and batch expansion quantity, and automatically generate PI** after saving;

The UDI is the unique device identifier and the UDI code should be applied to the issuing authority.

What is UDI, UDI (Unique Device Identification) is an "ID card" of medical devices. The "ID card" includes the product information of the device and the production-related information, which is the only one.

1. The basis of accurate identification of medical devices runs through the entire life cycle of early infiltration, circulation and use of medical Lu Qizhi devices.

UDI is a string of symbols, numbers or letters** that are generally attached to medical device products and packaging.

It is also the most important part of the unique identification system or bending system of medical devices, with a unique mold hand in the world, which can be used for accurate identification of medical device products, which is convenient for supervision and traceability.

According to Article 3 of the Regulations for the Unique Identification System for Medical Devices or the Rules for Limb Elimination, the unique device identification (UDI) refers to the unique identification of medical devices and medical devices by numbers, letters or symbols attached to the packaging of medical device products or hungry makers.

UDI is applying in **? According to Article 10 of the Rules for the Unique Identification System of Medical Devices, the issuing agency of the unique identification of medical devices shall be a legal entity in China, with a sound management system and operation system to ensure the uniqueness of the unique identification of medical devices created in accordance with its standards and meet the relevant requirements of data security in China.

UDI printing detection and filial piety unwrapping and closing of the sedan car to make a decision.

This kind of thing has an organization.

Summary. UDI is the unique identification of medical devices as defined by the regulatory authorities, and the standards such as Global Item (GTIN) and Additional Attributes (Application Identifiers) in the Commodity Barcode Standards System (GS1 System) are the national standards that can be used to implement UDI. The method of applying for a product barcode is as follows:

1) Log in to the official website of China Article Coding Center for online registration (2) China Coding APP (3) WeChat applet China Article Coding Center Online Business Hall (4) Go to the branch window for processing (5) Submit information: China Commodity Barcode System Member Registration Form Copy and copy of business license or business license of enterprise legal person Copy of remittance voucher.

Hello, according to your question Apply for barcode has a loss state UDI phase resistance key off the statement to choose yes or not? I'll answer for you. The application barcode has a UDI-related Changkong Qiao declaration to choose is.

UDI is the unique identification of medical devices defined by the regulatory authorities, and the standards such as Global Item (GTIN) and Additional Attributes (Application Identifier) in the Commodity Barcode Standard System (GS1 System) are the national standards that can be used to implement UDI. The method of applying for a commodity bar return code is as follows: (1) log in to the official website of the China Article Coding Center for online registration (2) China Coding APP (3) WeChat applet China Goods Coding Center Online Business Hall (4) Go to the branch window for processing (5) Submit information:

China Commodity Barcode System Member Registration Form Copy and copy of business license or business license of enterprise legal person Copy of remittance voucher.

Summary. UDI (Unique Device Identification) is a kind of medical device product or packaging, composed of numbers, letters or symbols, to uniquely identify medical devices.

Hello, I have seen your question, please wait for five minutes while I am sorting out the answer for you. If you feel that I am helpful to you, please move your little hands and give me a thumbs up, okay?

I choose whether it is or not.

It doesn't matter, I'm a confectionery producer.

UDI (Unique Device Identification) is a kind of unique identification of medical devices attached to the product or packaging of medical devices, composed of numbers, letters or symbols, which is used to uniquely identify and answer the spine of medical devices.

There will be no other impact, if yes, it is for commercial use, and if it is not, it is for personal and electric use.

If you choose no, it is for individual and store.

I'm a producer wholesale food and the supermarket needs my barcode?

Yes, there is no impact.

I just wholesale to supermarkets, and they want me to apply for barcodes to facilitate supermarket sales.

Is it right to choose no?

Enterprises that use registered trademarks on goods should have the right to register trademarks in principle when applying for registration of Chinese commodity barcode manufacturers. The legal use of other people's registrars and subject units, only on the premise that it does not violate the uniqueness of the commodity code, can apply for registration of Chinese commodity barcode manufacturers blind shed identification**.

Only medical institutions will choose yes.

You read the above clause carefully.

UDI is a unique device identification (abbreviated UDI), and the unique identification of medical devices refers to the unique identification of medical devices presented on the product or packaging of medical devices, which is composed of digital muslag skin, word Xunqi mother or symbol, which is used for unique identification of medical devices.

Its ** way is:

Official Coding Agency Creates Code Management Data Company (Factory) Scans and Codes to Track Products Company (Logistics Center) Automatic Sorting and Traceability Receipt Inspection and Quality Control Confirmation of Receipt Medical Liang Group Therapy Device Product Tracking Product, Patient Information Records and Product Recalls.

UDI is composed of the wheel recognition DI in the product standard and the production logo PI, which is indispensable for the early leakage. DI is the early state information of the product, which is a code containing the specific product name, packaging grade, specification and model. DI, which is a combination of enterprise code and product ID, is unique.

PI is dynamic information, including production date, expiration date of return, production batch, serial number, calibration location, etc.

UDI (Unique Device Identification) is a series of numbers, letters, or characters created through globally recognized device identification and coding standards. It can unambiguously identify medical devices on the market.

UDI consists of UDI-DI (Device Identifier) and UDI-PI (Manufacturing Identifier), which can include information about the lot number or serial number and can be used anywhere in the world.

Domestic UDI applications can be broken down into the following steps:

Step 1: Assemble an implementation team.

Enterprises first need to self-check and set up a UDI implementation team. If the conditions for forming a team are insufficient, or there is a high demand for implementation efficiency, you can choose a suitable professional UDI service organization to carry out the full-cycle work under the guidance and technical support of the professional team.

Step 2: Choose the right code issuing agency for you.

Enterprises need to choose and choose a suitable code issuing agency in accordance with the "Rules" and relevant standards in accordance with their own conditions. At present, there are three institutions certified by the Food and Drug Administration on the market: GS1, AHM, and AHM. If you only consider the Chinese market, you can choose any of the three code issuers mentioned above.

If you want to take into account overseas markets, you need to choose a GS1 institution that can meet the regulatory requirements of China, the EU and the US at the same time. (For details, please refer to the previous article "How Should Enterprises Choose the Right Code Issuing Agency When Implementing UDI?") 》)

Step 3: Make a UDI declaration.

After selecting the code issuing agency, it is necessary to declare the UDI:

The first is the registration application of DI, and the more common declaration process is: complete the registration and payment on the code issuance platform, get the DI code The enterprise codes and verifies according to the coding rules, and then logs in to the Food and Drug Administration platform to fill in the product information, and reports the DI code to the Food and Drug Administration platform The Food and Drug Administration database reviews all the reported DI data and publishes the declaration.

Step 4: UDI coding.

After the review is passed, it is necessary to start the label design, through the software to generate the corresponding data carrier and then code it to the product, if the use of RFID, must be accompanied by a one-dimensional code or *** label, the label in addition to the code map but also have Chinese label instructions, the printing quality of the label needs to meet the ISO15415 standard C level or above, at the same time the code of the UDI and the code map content to be consistent, one code and one picture, UDI also needs to comply with the AIDC and HRI principles. Different coding equipment requires different software and different operation modes.