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WiScope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OTU-C380RRModel OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR,
Identity
- Trade Name
- WiScope EUDAMEDWiScope® FDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDI
- Device Name
- Single-Use Digital Flexible Endoscope EUDAMEDSingle-Use Digital Flexible Cystoscope FDA UDI
- Model / Reference
- OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR, EUDAMEDOTU-C380RR EUDAMEDFDA UDI
- Description
- Single-Use Digital Flexible Cystoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972084140085 EUDAMEDFDA UDI
- Basic UDI-DI
- 697208414003H3 EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES 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 Ningbo Wise Optomech Technology Corporation — 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 | 697208414003H3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (2)
- EUDAMED 7d9deed5-0c34-4c27-b87f-3912958ddbf8 61 fields · synced May 30, 2026
- FDA UDI df12262d-38e7-49f3-8592-d34e51711786 33 fields · synced May 30, 2026