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WiScope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OTU-OM100RModel OTU-OM100SR, OTU-OM100RR, OTU-OM100SL, OTU-OM100RL, OTU-OM100S, OTU-OM100R
Identity
- Trade Name
- WiScope EUDAMEDWiScope® FDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- Single-Use Digital Flexible Ureteroscope/Choledochoscope EUDAMEDFDA UDI
- Model / Reference
- OTU-OM100SR, OTU-OM100RR, OTU-OM100SL, OTU-OM100RL, OTU-OM100S, OTU-OM100R EUDAMEDOTU-OM100R EUDAMEDFDA UDI
- Description
- Single-Use Digital Flexible Ureteroscope/Choledochoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850023925305 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850023925011RG EUDAMED
- FDA Product Code
- FGB FDA UDIFBN FDA UDI
- EMDN Code
- Z12020501 CHOLEDOCOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDI
Classification
- Device Class
- Class IIa 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
WiScope by Otu Medical Inc. — Class IIa — 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 | 0850023925011RG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 f8006e1e-2920-4e80-acb3-c9a3b1a7be52 61 fields · synced Jul 23, 2026
- FDA UDI b0c15b27-7a8a-47fe-8a47-1795e96a2229 33 fields · synced May 30, 2026