Identity
- Trade Name
- EG-550L EUDAMEDSonoScape FDA UDI
- Generic Name
- Flexible video gastroscope, reusable FDA UDI
- Device Name
- Video Gastroscope EUDAMEDEG-550L Video Gastroscope FDA UDI
- Model / Reference
- EG-550, EG-550L EUDAMED/ EUDAMEDEG-550L FDA UDI
- Description
- EG-550L Video Gastroscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868603434 EUDAMEDFDA UDI
- Basic UDI-DI
- 69458686EG-550MH EUDAMED
- Direct Marketing DI
- 06945868603434 EUDAMED
- 510(k) Number
- K211882 FDA UDI
- FDA Product Code
- FDS FDA UDI
- EMDN Code
- Z12020511 VIDEO GASTROSCOPES EUDAMED
- GMDN Term
- Flexible video gastroscope, reusable 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
Yes
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
Eg-550l 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-550MH | 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 4650c1a8-2086-400c-ae62-517c27f6e56f 61 fields · synced Oct 6, 2026
- FDA UDI ee7a6fd9-4ee9-49d3-aed1-c096dedceb25 34 fields · synced May 30, 2026