Nitrile examination gloves
- Risk class
- Class I
- CND nomenclatures code
- T01020204
- Trade name
- Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size M
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 06438129000351
- Basic UDI
- 6438129B0001GU
- Version date
- February 11, 2025
- Manufacturer last update
- May 09, 2023
- Active status
- No
- Manufacturer name
- OneMed Group Oy
- Country
- Finland
- Country type
- EU_MEMBER_STATE
- Address
- 20 Metsäläntie Helsinki
- eudamed.onemedgroup@onemed.com
- Competent authority
- Finnish Medicines Agency, Supervision and licences, Medical Device Unit
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Sweden
- Market available
- Sweden:2025-01-31~None, Finland:2025-01-31~None, Norway:2025-01-31~None, Denmark:2025-01-31~None, Estonia:2025-01-31~None, Latvia:2025-01-31~None, Lithuania:2025-01-31~None, Netherlands:2025-01-31~None, Belgium:2025-01-31~None, Luxembourg:2025-01-31~None, Germany:2025-01-31~None, Austria:2025-01-31~None, Poland:2025-01-31~None, Spain:2025-01-31~None, Portugal:2025-01-31~None
- Human tissues
- No
- Animal tissues
- No
NITRILE EXAMINATION / TREATMENT GLOVES
Access comprehensive regulatory information for Nitrile examination gloves in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 06438129000351 and manufactured by OneMed Group Oy in Finland.
This page provides complete registration details including trade name (Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size M), manufacturer information, competent authority (Finnish Medicines Agency, Supervision and licences, Medical Device Unit), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.