Identity
- Trade Name
- PENTAX USYFITVUE GP1 T25G45S EUDAMED
- Device Name
- PENTAX Surgical Loupes EUDAMED
- Model / Reference
- 2037049 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582428431155 EUDAMED
- Basic UDI-DI
- 4582428-TSU-0001QW EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Pentax Usyfitvue Gp1 T25g45s by HOYA Technosurgical Corporation — 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 | 4582428-TSU-0001QW | Class I | Active |
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Manufacturer
- Manufacturer
- HOYA Technosurgical Corporation
- EUDAMED SRN
- JP-MF-000045863
- Authorised Representative
- HOYA Holdings B.V. NL-AR-000004416
Sources (1)
- EUDAMED 44e96ce5-212f-4652-b09e-4c2db4bce117 61 fields · synced Jul 16, 2026