The FDA mandates the use of UDI 2D data matrix barcodes for most medical devices and pharmaceutical products. The UDI must be directly marked on the device packaging or label using automatic identification and data capture (AIDC) technology. Compliance timelines and requirements may vary depending on the product classification.

Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than one use...

2025年3月10日 · Fortunately the FDA UDI requirements allow for use of 2-dimensional (2D) barcodes. Compared to linear barcodes, 2D barcodes can encode all of the required UDI data fields in a significantly smaller area, allowing for easier integration into device packaging.

2021年3月24日 · UDI is a Two-part Barcode. The Unique Device Identifier or UDI is a barcode, most often containing two data sets. The primary data set is the Device Identifier (DI); the secondary set is a Production Identifier (PI). The DI identifies the …

According to the International Medical Device Regulators Forum (IMDRF), a Unique Device Identification (UDI) system is intended to provide a single, globally harmonised system for positive identification of medical devices through distribution and use.

2017年3月24日 · A UDI code aims at unambiguous identification of a specific medical device. To ensure a globally standardized and harmonized system, the UDI code must be issued under the rules of a U.S. FDA-accredited issuing agency or an EU-accredited assigning agency, which includes GS1. The UDI code is a unique, alphanumeric code, which consists of two parts:

Resmed adopted a 2D barcode, utilizing the GS1 Standards to comply with UDI requirements from the FDA. The 2D barcode provides greater flexibility than the 1D barcode used for our serial and catalog numbers.

The GS1 UDI barcode combines the Device Identifier (DI), also known as the GTIN by GS1.org, and the Production Identifier (PI).

A UDI is a unique numeric or alphanumeric code that consists of two parts: • a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and • a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the

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