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Surgical Loupe
EUDAMEDClass I (EU MDR)
Ref Galileo-FD-GL/3.5XRef Galileo-FR-GL/2.5XRef Galileo-FR-GL/3.5X
Identity
- Device Name
- Surgical Loupe EUDAMED
- Model / Reference
- Galileo-FD-GL/3.5X EUDAMEDGalileo-FR-GL/2.5X EUDAMEDGalileo-FR-GL/3.5X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976536010124 EUDAMED06976536010131 EUDAMED06976536010148 EUDAMED
- Basic UDI-DI
- 697653601G001F7 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER 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 Loupe 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 | 697653601G001F7 | 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 (3)
- EUDAMED 139f2f3d-7647-4a42-a6a0-9516ff1838b9 61 fields · synced Oct 6, 2026
- EUDAMED 6808eb4a-89b7-40c1-9e5f-b1151c8719ea 61 fields · synced May 19, 2026
- EUDAMED 751b26f7-a4ce-4ad5-9056-e8fcc0206434 61 fields · synced May 19, 2026