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Nitrile examination gloves - EUDAMED Registration 06438129000375

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 06438129000375 and manufactured by OneMed Group Oy in Finland.

This page provides complete registration details including trade name (Embraยฎ Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size L), 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.

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EUDAMED Official Data
Class I
06438129000375
No
Nitrile examination gloves
Trade Name: Embraยฎ Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size L
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Device Description (EMDN)

NITRILE EXAMINATION / TREATMENT GLOVES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
T01020204
Trade Name
Embraยฎ Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size L
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06438129000375
Basic UDI
6438129B0001GU
Version Date
February 11, 2025
Manufacturer Last Update
May 09, 2023
Active Status
No
Manufacturer
Manufacturer Name
OneMed Group Oy
Country
Finland
Country Type
EU_MEMBER_STATE
Address
20 Metsรคlรคntie Helsinki
Email
eudamed.onemedgroup@onemed.com
Regulatory Information
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, Austria:2025-01-31~None, Portugal:2025-01-31~None, Spain:2025-01-31~None, Poland:2025-01-31~None, Germany:2025-01-31~None, Luxembourg:2025-01-31~None, Belgium:2025-01-31~None, Netherlands:2025-01-31~None, Lithuania:2025-01-31~None, Latvia:2025-01-31~None, Estonia:2025-01-31~None, Denmark:2025-01-31~None, Norway:2025-01-31~None, Finland:2025-01-31~None
Device Characteristics
Human Tissues
No
Animal Tissues
No