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Stellar Fluorescence Camera Head
EUDAMEDFDA UDIClass I (EU MDR)
Ref SC20EModel SC20E
Identity
- Trade Name
- Stellar Fluorescence Camera Head EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Fluorescence Camera Head EUDAMED
- Model / Reference
- SC20E EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973031299412 EUDAMEDFDA UDI
- Basic UDI-DI
- 697303129SX20E01J9 EUDAMED
- Direct Marketing DI
- 06973031299412 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 Fluorescence Camera Head by Guangdong Optomedic Technologies, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697303129SX20E01J9 | 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 3c597339-60ff-40b5-8497-ab056e7ac8c9 61 fields · synced Jul 25, 2026
- FDA UDI 5f0791fe-9cda-4182-b472-b61b867c40a1 33 fields · synced May 30, 2026