Identity
- Trade Name
- Blue nitrile gloves XL EUDAMED
- Device Name
- Nitrile Examination Gloves, Powder Free, Blue color EUDAMED
- Model / Reference
- CCIR-00700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14897120160041 EUDAMED
- Basic UDI-DI
- 489712016CCIR-007005N EUDAMED
- Unit of Use DI
- 04897120167043 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
Blue nitrile gloves XL 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-007005N | 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 beb512bc-d95d-45ee-8049-cabc35491d8d 61 fields · synced Jun 18, 2026