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POPPY Powder-Free Nitrile Examination Gloves
EUDAMEDClass I (EU MDR)
Ref N030SKB-M
Identity
- Trade Name
- POPPY Powder-Free Nitrile Examination Gloves EUDAMED
- Device Name
- Nitrile Powder Free Examination Gloves EUDAMED
- Model / Reference
- N030SKB-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551025720387 EUDAMED
- Basic UDI-DI
- 95541005249035PFNPEGK4 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye 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
POPPY Powder-Free Nitrile Examination Gloves by Onetexx Sdn.bhd. — 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 | 95541005249035PFNPEGK4 | Class I | Active |
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Manufacturer
- Manufacturer
- Onetexx Sdn.bhd.
- EUDAMED SRN
- MY-MF-000024836
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED 695d332e-d109-4790-9e2b-d522b0946bb1 61 fields · synced Jun 18, 2026