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nitrylex black
EUDAMEDClass I (EU MDR)
Ref RD301040Q3Ref RD301040Q4Ref RD301040Q1Ref RD301040Q6
Identity
- Trade Name
- nitrylex black EUDAMED
- Device Name
- Non-sterile Powder Free Nitrile Examination gloves EUDAMED
- Model / Reference
- RD301040Q3 EUDAMEDRD301040Q4 EUDAMEDRD301040Q1 EUDAMEDRD301040Q6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08859185203773 EUDAMED08859185203780 EUDAMED08859185203759 EUDAMED08859185205494 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 black 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 (4)
- EUDAMED b5958076-23f3-4e80-977c-5addcc20bc49 61 fields · synced Oct 6, 2026
- EUDAMED e567e70c-dfee-4131-9280-b46ef07d1087 61 fields · synced May 16, 2026
- EUDAMED 60e1e534-9da5-47e7-9751-29ba3a975e05 61 fields · synced May 18, 2026
- EUDAMED 5e8ab94a-d4e4-4c74-8b86-8e556a28fa74 61 fields · synced May 18, 2026