Identity
- Trade Name
- Black nitrile gloves M EUDAMED
- Device Name
- Black nitrile examination gloves, Powder free EUDAMED
- Model / Reference
- CCIR-007107 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897120160072 EUDAMED
- Basic UDI-DI
- 489712016CCIR-007105R EUDAMED
- Unit of Use DI
- 04897120167074 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Black nitrile gloves M by Ccir Asia Pacific Limited — 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 | 489712016CCIR-007105R | Class I | Active |
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Manufacturer
- Manufacturer
- Ccir Asia Pacific Limited
- EUDAMED SRN
- HK-MF-000003035
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 1eebb5b2-2561-450e-b901-b326dd3d38eb 61 fields · synced Jul 22, 2026