Identity
- Device Name
- Light Handle Cover EUDAMED
- Model / Reference
- GC9005B02 EUDAMEDGC/CE-42 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970754496227 EUDAMED
- Basic UDI-DI
- 697075449F01OP060059P EUDAMED
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Light Handle Cover by Gcmedica Enterprise Ltd.(wuxi) — 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 | 697075449F01OP060059P | Class I | Active |
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Manufacturer
- Manufacturer
- Gcmedica Enterprise Ltd.(wuxi)
- EUDAMED SRN
- CN-MF-000008756
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 56c8d28e-cd79-4f10-b2ac-2acd759d9b0b 61 fields · synced Jun 18, 2026