← Back to catalogue
PENTAX Medical Ultrasound Upper G.I. Video Scope EG34-J10U
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 6217001S207SModel See UDI-DI information for model names
Identity
- Trade Name
- PENTAX Medical Ultrasound Upper G.I. Video Scope EG34-J10U EUDAMED
- Device Name
- PENTAX Medical Ultrasound Upper G.I. Video Scope EUDAMED
- Model / Reference
- See UDI-DI information for model names EUDAMED6217001S207S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04961333239702 EUDAMED
- Basic UDI-DI
- 4961333010201XH EUDAMED
- Direct Marketing DI
- 04961333239542 EUDAMED
- EMDN Code
- Z12020503 ECHO–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 Ultrasound Upper G.I. Video Scope EG34-J10U by HOYA Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
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 | K203166 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4961333010201XH | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- HOYA Corporation
- EUDAMED SRN
- JP-MF-000005227
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED bb0e375d-9492-406e-9079-96850f591bb5 61 fields · synced Oct 6, 2026
- FDA 510(k) K203166 1 fields · synced May 18, 2026