Identity
- Trade Name
- Stellar EUDAMEDStellar Image Processing Unit EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Fluorescence Camera Head EUDAMEDImage Processing Unit EUDAMED
- Model / Reference
- SC30E EUDAMEDSI10E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299313 EUDAMED06973031299436 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129SC30E01A3 EUDAMED697303129GK20E016L EUDAMED
- Direct Marketing DI
- 06973031299313 EUDAMED
- 510(k) Number
- K241530 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMEDZ12020499 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER EUDAMED
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMEDIreland 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
EUDAMEDEUDAMED
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
Stellar by Guangdong Optomedic Technologies, Inc. — Class I — 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 | 697303129SC30E01A3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Guangdong Optomedic Technologies, Inc.
- EUDAMED SRN
- CN-MF-000011588
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED c4d5faa2-f233-41c0-b584-3cf149e0f5df 61 fields · synced Jul 31, 2026
- EUDAMED 94c42a0e-d8d2-4660-9dc0-9e6e52746bb9 61 fields · synced May 17, 2026
- FDA UDI 89db4d33-33fd-4fe8-b52e-8c58c687a836 33 fields · synced May 30, 2026