WiScope
EUDAMEDFDA UDIClass IIa (EU MDR)
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 Ureteroscope FDA UDI
- Model / Reference
- OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-C380RL, OTU-C380RR, OTU-C380SL, OTU-C380SR, EUDAMEDOTU-100RR EUDAMEDFDA UDI
- Description
- Single-Use Digital Flexible Ureteroscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972084140023 EUDAMEDFDA UDI
- Basic UDI-DI
- 697208414003H3 EUDAMED
- FDA Product Code
- FGB FDA UDI
- EMDN Code
- Z12020713 URETERORENOSCOPES 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Flexible video ureteroscope, single-use
WiScope by Ningbo Wise Optomech Technology Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video ureteroscope, single-use.
- Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
- Ureterorenoscope — Innoview GmbH · Class IIa
- WiScope® — OTU MEDICAL INC. · Class II
- URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
- CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
- LithoVue — Boston Scientific · Class II
- Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
- Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 77586baf-d469-474c-8965-83285e403144 61 fields · synced Jun 8, 2026
- FDA UDI e0cc4156-e962-407c-a6fa-f54fe24be475 33 fields · synced May 30, 2026