Identity
- Trade Name
- Quantus Medical Nitril EUDAMED
- Device Name
- Nitrile Powder Free Examination Gloves EUDAMED
- Model / Reference
- (QM5218101YNB-S)(N035MNV) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09554100524900 EUDAMED
- Basic UDI-DI
- 95541005249035PFNPEGK4 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Quantus Medical Nitril 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 e47fcb56-b1f5-478f-83b5-27989f842a01 61 fields · synced Jun 19, 2026