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PENTAX Medical Video Upper GI Scope EG17-J10
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6217001S257SModel See UDI-DI information for model names
Identity
- Trade Name
- PENTAX Medical Video Upper GI Scope EG17-J10 EUDAMED
- Device Name
- PENTAX Medical Video Upper GI Scope EUDAMED
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001S257S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04961333246038 EUDAMED
- Basic UDI-DI
- 4961333010104XJ EUDAMED
- Direct Marketing DI
- 04961333246007 EUDAMED
- EMDN Code
- Z12020511 VIDEO GASTROSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 Medical Video Upper GI Scope EG17-J10 by HOYA Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K210177 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4961333010104XJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 1d5dd1dd-0b59-4fa4-af5d-9de4a53a0873 61 fields · synced Jul 21, 2026
- FDA 510(k) K210177 1 fields · synced May 18, 2026