Identity
- Trade Name
- PURE EUDAMED
- Device Name
- GLOVES EUDAMED
- Model / Reference
- 231784 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250476646127 EUDAMED
- Basic UDI-DI
- 42504766GLOUP EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Pure by Akzenta International SA — 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 | 42504766GLOUP | Class I | Active |
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Manufacturer
- Manufacturer
- Akzenta International SA
- EUDAMED SRN
- CH-MF-000036434
- Authorised Representative
- IQX GmbH AT-AR-000016713
Sources (1)
- EUDAMED 12e471d3-9fdd-4e47-a77d-be7437b8437b 61 fields · synced Jun 19, 2026