UDI唯一器械标识
Unique Device Identification (UDI) is a numeric or alphanumeric code assigned to a medical device to identify its labeler, device version, and production details across distribution and use. In life-science translation, it appears in device labeling, registration submissions, distribution records, adverse-event reports, and supply-chain documentation, often as UDI-DI and UDI-PI components.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Translators encounter UDI in device labels, technical documentation, registration dossiers, hospital inventory systems, and adverse-event reporting forms. It often appears in barcode specifications, label mock-ups, packaging artwork, and supply-chain data descriptions, requiring consistent handling of abbreviations and data format instructions across markets.
Translation checks
A frequent error is treating UDI as a free-text label name or translating its components loosely. UDI is structured data; changing the order, hyphenation, or meaning of terms like product identifier versus production identifier can introduce tracking and vigilance errors across barcode, label, and database systems, potentially affecting adverse-event reports and recalls.
Chinese document application
UDI in context · device label
- English source
- Keep the device identifier unchanged in the translated label.
- Chinese rendering to review
- 在译后标签中保持器械标识符不变。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
An identifier is not ordinary label prose. Separate encoded or approved identifier content from surrounding text before translation. Chinese wording should not alter a code, introduce spaces into it or substitute a translated product name for an identifier.
Check the returned Chinese file
Compare the protected identifier field before and after Chinese layout. Check for inserted spaces, altered character case or a line break that could make the displayed identifier differ from the manufacturer-approved content.
Prepare the connected files
Send the artwork and the manufacturer’s protected-field instructions. Confirm which identifiers, symbols and text fields may be edited and who approves the final proof.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.