Identity
- Device Name
- Surgical Telescope EUDAMED
- Model / Reference
- Looks2500 EUDAMEDLooks7500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800157700073 EUDAMED
- Basic UDI-DI
- 88001577LOOKS0000H8 EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I 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 Telescope by Xenosys 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 | 88001577LOOKS0000H8 | Class I | Active |
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Manufacturer
- Manufacturer
- Xenosys Co., Ltd.
- EUDAMED SRN
- KR-MF-000054663
- Authorised Representative
- S.B. Pharma GmbH DE-AR-000005392
Sources (1)
- EUDAMED 11d00f6c-c42c-4695-beec-02a032cb0598 61 fields · synced Jul 14, 2026