Identity
- Device Name
- Surgical Telescope EUDAMED
- Model / Reference
- Looks2500 EUDAMEDLooks2700AH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800157700288 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
Category: Surgical binoculars, reusable
Surgical Telescope by Xenosys Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 ac8090d5-d06c-4691-a5d2-c52dee6ad8cc 61 fields · synced Jun 18, 2026