Identity
- Trade Name
- WiScope EUDAMEDWiScope® FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Image System/Medical Tablet EUDAMEDImage System, adapting to a monitor of 4:3 aspect ratio. FDA UDI
- Model / Reference
- OTU-A, OTU-T, EUDAMEDOTU-A EUDAMEDFDA UDI
- Description
- Image System, adapting to a monitor of 4:3 aspect ratio. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972084140054 EUDAMEDFDA UDI
- Basic UDI-DI
- 697208414005H7 EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020406 VIDEO PROCESSORS 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
- Northern 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
WiScope by Otu Medical 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 | 697208414005H7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ningbo Wise OptoMech Technology Corporation
- EUDAMED SRN
- CN-MF-000036849
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (3)
- EUDAMED afb4de58-5d01-4044-975d-d500029e760b 61 fields · synced May 30, 2026
- EUDAMED e9c3af6a-743c-4897-91f5-0cb2ac341b50 61 fields · synced May 19, 2026
- FDA UDI 8cb98140-4694-42fe-bec1-8e34d7d0587b 33 fields · synced May 30, 2026