Identity
- Trade Name
- Stellar Camera Head EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Camera Head EUDAMED
- Model / Reference
- SC10E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299429 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129SX20D01J4 EUDAMED
- Direct Marketing DI
- 06973031299429 EUDAMED
- 510(k) Number
- K241530 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS 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
- Ireland 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
Hydrogen Peroxide FDA UDI
Stellar Camera Head 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 | 697303129SX20D01J4 | 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 (2)
- EUDAMED 71f17f20-d12c-4cf1-966e-525942f152cb 61 fields · synced Jun 19, 2026
- FDA UDI b9b48265-bac8-4d42-8e71-1c2df5e9c6f9 33 fields · synced May 29, 2026