Identity
- Trade Name
- nitrylex classic A100 EUDAMED
- Device Name
- Non-sterile Powder Free Nitrile Examination gloves EUDAMED
- Model / Reference
- RD300199Q6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859185207207 EUDAMED
- Basic UDI-DI
- 88591852NSNPF6S EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
nitrylex classic A100 by Mercator Medical (Thailand) Ltd. — 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 | 88591852NSNPF6S | Class I | Active |
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Manufacturer
- Manufacturer
- Mercator Medical (Thailand) Ltd.
- EUDAMED SRN
- TH-MF-000042229
- Authorised Representative
- Mercator Medical S.A. PL-AR-000029843
Sources (1)
- EUDAMED 360d7060-391d-4caf-8490-73cc0afcffc7 61 fields · synced Oct 7, 2026