Identity
- Trade Name
- HL EUDAMED
- Device Name
- Headlamp EUDAMED
- Model / Reference
- HL EUDAMEDFTIHL EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-00862658000326HZ EUDAMED
- Basic UDI-DI
- B-00862658000326HZ EUDAMED
- EMDN Code
- L0318 INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Hl by Fiberoptics Technology Incorporated — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00862658000326HZ | Class I | Active |
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Manufacturer
- Manufacturer
- Fiberoptics Technology Incorporated
- EUDAMED SRN
- US-MF-000018020
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 3243c6e2-0a89-4fb7-8a1e-272d2792621e 61 fields · synced Jul 9, 2026