Identity
- Trade Name
- HL8200 EUDAMED
- Device Name
- Headlight EUDAMED
- Model / Reference
- 572-0060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095541912 EUDAMED
- Basic UDI-DI
- 69450955headlight7K EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Hl8200 by Zumax Medical 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 | 69450955headlight7K | Class I | Active |
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Manufacturer
- Manufacturer
- Zumax Medical CO., LTD.
- EUDAMED SRN
- CN-MF-000011126
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED cee8db3f-18e1-4238-8192-f1093053e33e 61 fields · synced Oct 6, 2026