Identity
- Trade Name
- ALUMINIUM Nitrile 3.5 black MDR EUDAMED
- Device Name
- Disposable Nitrile Exam Gloves EUDAMED
- Model / Reference
- EM.6775 EUDAMEDEM.6773 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08994468290054 EUDAMED08994468290030 EUDAMED
- Basic UDI-DI
- 899446829NBR34 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ALUMINIUM Nitrile 3.5 black MDR by Pt Basic International Sumatera — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 899446829NBR34 | Class I | Active |
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Manufacturer
- Manufacturer
- Pt Basic International Sumatera
- EUDAMED SRN
- ID-MF-000050694
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (2)
- EUDAMED 9a4bc758-78d6-48a6-a71f-66d248621ced 61 fields · synced Aug 2, 2026
- EUDAMED e8866b68-6565-444a-8339-5971ba7dc784 61 fields · synced May 19, 2026