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WiScope
EUDAMEDFDA UDIClass I (EU MDR)
Ref OTU-TModel OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01
Identity
- Trade Name
- WiScope EUDAMEDWiScope® FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- Image System/Medical Tablet EUDAMEDImage System FDA UDI
- Model / Reference
- OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01 EUDAMEDOTU-T EUDAMEDFDA UDI
- Description
- Image System FDA UDI
Identifiers
- Catalog Number
- 4202T0101T FDA UDI
- Primary DI / UDI-DI
- 00850023925312 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850023925003RH EUDAMED
- 510(k) Number
- K231702 FDA UDI
- FDA Product Code
- FAJ 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
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
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 | 0850023925003RH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Otu Medical Inc.
- EUDAMED SRN
- US-MF-000020690
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 24dd5080-3f57-48b3-a77c-0f565ffb01cb 61 fields · synced Jun 8, 2026
- FDA UDI fb37f6f7-96ad-4c2c-a612-3db748b49bdd 35 fields · synced May 29, 2026