Identity
- Trade Name
- PENTAX USYFITVUE GP1 T25G40B EUDAMED
- Device Name
- PENTAX Surgical Loupes EUDAMED
- Model / Reference
- 2037045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582428431100 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
Pentax Usyfitvue Gp1 T25g40b by HOYA Technosurgical Corporation — 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 | 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 3cb5c70a-1882-4036-ae06-c8bf8711bdd4 61 fields · synced Jul 11, 2026