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Surgical Headlight
EUDAMEDClass I (EU MDR)
Ref Aspholight-FD-B8Ref Aspholight-FD-P5Ref Aspholight-FD-L8Ref Aspholight-FD-P8Ref Aspholight-FD-L5Ref Aspholight-FD-N5Ref Aspholight-FD-N8
Identity
- Device Name
- Surgical Headlight EUDAMED
- Model / Reference
- Aspholight-FD-B8 EUDAMEDAspholight-FD-P5 EUDAMEDAspholight-FD-L8 EUDAMEDAspholight-FD-P8 EUDAMEDAspholight-FD-L5 EUDAMEDAspholight-FD-N5 EUDAMEDAspholight-FD-N8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976536010025 EUDAMED06976536010070 EUDAMED06976536010049 EUDAMED06976536010087 EUDAMED06976536010032 EUDAMED06976536010056 EUDAMED06976536010063 EUDAMED
- Basic UDI-DI
- 697653601A001DV EUDAMED
- EMDN Code
- L80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Surgical Headlight by Zhejiang FuDe Medphotonic 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 | 697653601A001DV | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang FuDe Medphotonic Co., Ltd.
- EUDAMED SRN
- CN-MF-000036121
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (7)
- EUDAMED 8306d65e-7a09-4e51-8899-43398f0e6cbd 61 fields · synced Oct 6, 2026
- EUDAMED 08d2513d-0475-4a25-8847-d50883c76470 61 fields · synced May 16, 2026
- EUDAMED b168c972-f841-4437-ad1f-215a2ce0eecf 61 fields · synced May 17, 2026
- EUDAMED 4b23f02f-57d7-42ff-bc36-1de0ff252b8d 61 fields · synced May 18, 2026
- EUDAMED 065cb146-ee7e-4234-a089-444585052ee5 61 fields · synced May 18, 2026
- EUDAMED b36084a3-b871-4b8f-b546-147ab0840ba0 61 fields · synced May 18, 2026
- EUDAMED f21908c1-2fd1-4143-9aec-7c48ea369d71 61 fields · synced May 19, 2026