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ALUMINIUM Nitrile 3.5 blue MDR
EUDAMEDClass I (EU MDR)
Ref EM.6500Ref EM.6499Ref EM.6498Ref EM.6727
Identity
- Trade Name
- ALUMINIUM Nitrile 3.5 blue MDR EUDAMED
- Device Name
- Disposable Nitrile Exam Gloves EUDAMED
- Model / Reference
- EM.6500 EUDAMEDEM.6499 EUDAMEDEM.6498 EUDAMEDEM.6727 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08994468290221 EUDAMED08994468290214 EUDAMED08994468290207 EUDAMED08994468290238 EUDAMED
- Basic UDI-DI
- 899446829NBR34 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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 blue 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 (4)
- EUDAMED e9245849-4eaf-432c-91c7-abc65e9c8887 61 fields · synced Sep 17, 2026
- EUDAMED 63f04875-35ff-43c2-bab1-04e1a1116720 61 fields · synced May 17, 2026
- EUDAMED 20d3468b-ef13-4e88-8ea1-555d33f40561 61 fields · synced May 18, 2026
- EUDAMED fb98688e-3481-4872-becb-e4c555948d18 61 fields · synced May 18, 2026