What does the Unique Medical Device Identification UDI include

UDI (Unique Device Identifier) for medical enterprises refers to a set of identification code systems introduced to uniquely identify and manage medical enterprises. The UDI system is designed to improve the efficiency and accuracy of medical device traceability management, risk assessment, accident reporting and recalls. The global implementation of UDI systems helps improve the safety and transparency of medical devices.

The unique identification of medical enterprises UDI usually consists of globally unique identification codes, such as unified company identification code (GS1 company barcode), International Standard Book Number (ISBN), International Article Number (GTIN), etc. By adding UDI codes to the packaging, labels, and products themselves of medical devices, unique identification and tracking of medical companies can be ensured.

The unique identification of medical devices UDI generally includes the following contents.

1. Device identifier

The device identifier in medical devices is a key component of the UDI system and is a code used to uniquely identify a medical device and a specific model.

1. Manufacturer information: The device identifier contains information about the manufacturer or supplier of the medical device, which can help identify the source and responsibility of the device.

2. Product description: Through the device identifier, you can understand the specific model, specifications, functions and other information of the medical device, helping medical institutions, patients and regulatory agencies to better identify and understand the device.

The UDI system requires that device identifiers be globally unique, that is, medical devices from different manufacturers or different models cannot have the same device identifier. This ensures accurate identification and tracking of medical devices worldwide. Device identifiers can be presented in various forms, such as barcodes, QR codes, etc., to facilitate automatic identification and collection. In addition, device identifiers can also be displayed in text form to facilitate human reading and understanding.

2. Production identifier

The medical device production identifier is another important component of the medical device UDI, which is used to identify the production batch, serial number, production date, validity period and other information of the medical device.

1. Production batch number: The specific batch number of a medical device during the manufacturing process helps track the production and quality assurance of this batch of medical devices.

2. Serial number: The unique serial number of a medical device during the production process is used to distinguish different device entities and is of great significance in terms of traceability and after-sales service.

3. Production date: Identifies the actual production date of the medical device, which is used to determine its validity period and quality assurance period.

4. Validity period: The effective period of use of a medical device, which can be used to remind medical institutions to replace or scrap the device in time before it expires.

Through production identifiers, medical institutions and regulatory authorities can accurately track and record the production, quality, expiration date and other information of medical devices. This helps ensure the quality and safety of medical devices and improves patients’ medical security.

3. Card form code

The card form code in medical device UDI is a display form of UDI. It displays the UDI encoded information in text form to facilitate manual reading and understanding.

1. Manufacturer information: Displays the manufacturer or supplier information of medical devices, allowing users to quickly understand the source and responsibility of the device.

2. Product description: Provide detailed model, specifications, functions and other information of medical devices to help users understand and identify the devices.

3. Device identifier: Displays the device identifier of the medical device, which is used to uniquely identify the device and a specific model.

4. Production identifier: Displays the production batch, serial number, production date, validity period and other information of the medical device.

Card form codes are generally displayed in an easy-to-read format, such as text, numbers, etc., and usually appear on the label, packaging or product itself of medical devices. It allows people to directly read and understand the UDI encoded information of medical devices without using special equipment or Tools to decode.

4. Machine readable code

The machine-readable code in medical device UDI displays the UDI-encoded information in a machine-readable form.

1. Device identifier: A code used to uniquely identify a medical device and a specific model.

2. Production identifier: identifies the production batch, serial number, production date, validity period and other information of the medical device.

The advantage of machine-readable codes lies in its efficiency and accuracy, which can realize automated data collection, traceability and management in all aspects of medical institutions and supply chains. This will help improve the traceability and safety of medical devices, and strengthen the regulatory agency's ability to supervise and manage medical devices.

Through machine-readable codes, not only can medical devices be quickly identified and tracked, but also better inventory management, convenient after-sales service, rapid recalls and resolution of quality issues can be achieved. At the same time, machine-readable codes also provide patients with more accurate and convenient transparency, allowing them to better understand and manage the medical devices they use.