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Imaging Processor System (Including Light Source)
EUDAMEDFDA UDIClass I (EU MDR)
Ref PL-2100Model PL-1000,PL-2000,PL-2100
Identity
- Trade Name
- lmaging Processor System (lncluding Light Source) FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Imaging Processor System (Including Light Source) EUDAMED
- Model / Reference
- PL-1000,PL-2000,PL-2100 EUDAMEDPL-2100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973786290139 EUDAMEDFDA UDI
- Basic UDI-DI
- 697378629PL7K EUDAMED
- 510(k) Number
- K241532 FDA UDI
- FDA Product Code
- FET FDA UDIKQM FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS EUDAMED
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4160 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Imaging Processor System (Including Light Source) by Shanghai SeeGen Photoelectric Technology Co., Ltd — 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 | 697378629PL7K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Shanghai SeeGen Photoelectric Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015374
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED b64540f8-ed2f-4350-8770-c6b57d426446 61 fields · synced Jul 9, 2026
- FDA UDI e3e21415-e5b6-4d3b-a860-f5554c84510a 33 fields · synced May 29, 2026