Identity
- Trade Name
- EndoScreener EUDAMEDFDA UDI
- Generic Name
- Endoscopic video image interpretive software FDA UDI
- Device Name
- Computer aided detection software for colorectal polyps EUDAMED
- Model / Reference
- WIPD01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973770840012 EUDAMEDFDA UDI
- Basic UDI-DI
- 697377084ESR101QF EUDAMED
- 510(k) Number
- K211326 FDA UDI
- FDA Product Code
- QNP FDA UDI
- EMDN Code
- Z12020682 LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Endoscopic video image interpretive software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1520 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
EndoScreener by Chengdu Wision Medical Device Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211326 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697377084ESR101QF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Wision Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000014430
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (3)
- EUDAMED 2d7e8762-b10f-4f29-9605-e56b2f0719c9 61 fields · synced Jul 10, 2026
- FDA UDI f4f16cc6-6372-4af8-ad80-538b41582440 34 fields · synced May 30, 2026
- FDA 510(k) K211326 1 fields · synced May 18, 2026