Identity
- Trade Name
- Headlight with Binocular Loupes EUDAMED
- Device Name
- Headlight EUDAMEDHeadlight with Binocular Loupe EUDAMED
- Model / Reference
- 556-2534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945095546207 EUDAMED
- Basic UDI-DI
- 69450955headlight7K EUDAMED69450955headlightloupes6E EUDAMED
- EMDN Code
- Z12010702 MOBILE SCIALYTIC LAMPS EUDAMEDQ0299,Z12010702 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
Headlight with Binocular Loupes 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 (2)
- EUDAMED 91b14679-f98c-4666-8647-093557bf70e7 61 fields · synced Oct 7, 2026
- EUDAMED e727bbd7-d59b-45d4-b469-47cf82098f36 61 fields · synced Oct 7, 2026