Identity
- Trade Name
- BiLumix® Gen. 2 EUDAMED
- Device Name
- Head Lamp EUDAMED
- Model / Reference
- KN-007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800271100001 EUDAMED
- Basic UDI-DI
- 88002711KN-0005H EUDAMED
- EMDN Code
- Z129004 LIGHT SOURCES 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
BiLumix® Gen. 2 by ChoiceTech Co., Ltd. — 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 | 88002711KN-0005H | Class I | Active |
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Manufacturer
- Manufacturer
- ChoiceTech Co., Ltd.
- EUDAMED SRN
- KR-MF-000044226
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED 021be6ee-8b9a-45f9-981a-28a56e63106b 61 fields · synced Jul 12, 2026