Identity
- Trade Name
- EG-UR5 EUDAMEDSonoScape FDA UDI
- Generic Name
- Flexible ultrasound gastroduodenoscope FDA UDI
- Device Name
- Ultrasonic Gastrovideoscope EUDAMEDEG-UR5 Ultrasonic Gastrovideoscope FDA UDI
- Model / Reference
- EG-UR5 EUDAMEDFDA UDI- EUDAMED
- Description
- EG-UR5 Ultrasonic Gastrovideoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868603472 EUDAMEDFDA UDI
- Basic UDI-DI
- 69458686EG-UR5VA EUDAMED
- Direct Marketing DI
- 06945868603472 EUDAMED
- 510(k) Number
- K231813 FDA UDI
- FDA Product Code
- ODG FDA UDI
- EMDN Code
- Z12020503 ECHO–GASTROSCOPES EUDAMED
- GMDN Term
- Flexible ultrasound gastroduodenoscope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Eg-Ur5 by Sonoscape Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69458686EG-UR5VA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED a4070a75-e902-4626-90e8-e143378f5dce 61 fields · synced Oct 6, 2026
- FDA UDI 34904663-8b7e-468c-835a-e5cc092292e3 34 fields · synced May 30, 2026