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WiScope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref OTU-C380RLModel OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330RRef OTU-C320SRef OTU-HY01SModel OTU-HY01S, OTU-HY01C, OTU-HY02S, OTU-HY02C, OTU-HY03S, OTU-HY03C, OTU-HY04S, OTU-HY04CRef OTU-C330SRef OTU-HY03CRef OTU-RL03Model OTU-RL01, OTU-RL02, OTU-RL03Ref OTU-HY02SRef OTU-A ProModel OTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01Ref OTU-C380SRRef OTU-OM100SLModel OTU-OM100SR, OTU-OM100RR, OTU-OM100SL, OTU-OM100RL, OTU-OM100S, OTU-OM100RRef OTU-100SLModel OTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S,Ref OTU-120SRef OTU-HY01CRef OTU-C320RRef OTU-C310SRef OTU-HY04S
Identity
- Trade Name
- WiScope EUDAMEDWiScope® FDA UDI
- Generic Name
- Flexible video ureteroscope, single-use FDA UDIFlexible video choledochoscope, single-use FDA UDIFlexible video cystoscope, single-use FDA UDI
- Device Name
- Single-Use Digital Flexible Cystoscope EUDAMEDFDA UDISingle-Use Digital Hysteroscope EUDAMEDSingle-Use Digital Flexible Rhino-Laryngoscope EUDAMEDImage System/Medical Tablet EUDAMEDSingle-Use Digital Flexible Ureteroscope EUDAMEDFDA UDISingle-Use Digital Flexible Ureteroscope/Choledochoscope EUDAMEDFDA UDI
- Model / Reference
- OTU-C300S, OTU-C300R, OTU-C310S, OTU-C310R, OTU-C311S, OTU-C311R, OTU-C380SL, OTU-C380RL, OTU-C380SR, OTU-C380RR, OTU-C320S, OTU-C320R, OTU-C330S, OTU-C330R EUDAMEDOTU-C380RL EUDAMEDOTU-C320S EUDAMEDOTU-HY01S, OTU-HY01C, OTU-HY02S, OTU-HY02C, OTU-HY03S, OTU-HY03C, OTU-HY04S, OTU-HY04C EUDAMEDOTU-HY01S EUDAMEDOTU-C330S EUDAMEDOTU-HY03C EUDAMEDOTU-RL01, OTU-RL02, OTU-RL03 EUDAMEDOTU-RL03 EUDAMEDOTU-HY02S EUDAMEDOTU-A, OTU-T, OTU-A Pro, OTU-T Pro, BDVP01 EUDAMEDOTU-A Pro EUDAMEDOTU-C380SR EUDAMEDOTU-100SL EUDAMEDFDA UDIOTU-OM100SL EUDAMEDFDA UDIOTU-120S EUDAMEDFDA UDIOTU-C310S EUDAMEDFDA UDIOTU-OM100SR, OTU-OM100RR, OTU-OM100SL, OTU-OM100RL, OTU-OM100S, OTU-OM100R EUDAMEDOTU-100RL, OTU-100RR, OTU-100SL, OTU-100SR, OTU-120R, OTU-120S, EUDAMEDOTU-HY01C EUDAMEDOTU-C320R EUDAMEDOTU-HY04S EUDAMED
- Description
- Single-Use Digital Flexible Ureteroscope FDA UDISingle-Use Digital Flexible Ureteroscope/Choledochoscope FDA UDISingle-Use Digital Flexible Cystoscope FDA UDI
Identifiers
- Catalog Number
- 4101U0301T FDA UDI4101U0501T FDA UDI
- Primary DI / UDI-DI
- 00850023925459 EUDAMED00850023925565 EUDAMED00850023925404 EUDAMED00850023925589 EUDAMED00850023925510 EUDAMED00850023925374 EUDAMED00850023925480 EUDAMED00850023925541 EUDAMED00850023925466 EUDAMED00850023925060 EUDAMEDFDA UDI00850023925251 EUDAMEDFDA UDI00850023925336 EUDAMEDFDA UDI00850023925183 EUDAMEDFDA UDI00850023925411 EUDAMED00850023925572 EUDAMED00850023925527 EUDAMED
- Basic UDI-DI
- 0850023925005RM EUDAMED0850023925013RL EUDAMED0850023925009RV EUDAMED0850023925003RH EUDAMED0850023925011RG EUDAMED0850023925002RF EUDAMED
- FDA Product Code
- FGB FDA UDIFBN FDA UDIFAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMEDZ12020704 HYSTEROSCOPES EUDAMEDZ12021005 NASAL PHARYNGO/LARYNGOSCOPES EUDAMEDZ12020406 VIDEO PROCESSORS EUDAMEDZ12020501 CHOLEDOCOSCOPES EUDAMEDZ12020713 URETERORENOSCOPES EUDAMED
- GMDN Term
- Flexible video ureteroscope, single-use FDA UDIFlexible video choledochoscope, single-use FDA UDIFlexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
Yes
EUDAMEDFDA UDIEUDAMED
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 | 0850023925005RM | 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 (20)
- EUDAMED 5ed9ec07-ecee-43a3-9bb7-67a35db1f1d7 61 fields · synced Sep 30, 2026
- EUDAMED 59275b10-a276-42f6-a230-75d00b1a711a 61 fields · synced May 16, 2026
- EUDAMED bc47e24b-5b70-44f7-917b-8363e14279f1 61 fields · synced May 17, 2026
- EUDAMED 278cc999-620c-4332-a508-0814afe785ba 61 fields · synced May 17, 2026
- EUDAMED 28da0606-14e4-4630-a2ef-3eb8f46cfbc8 61 fields · synced May 18, 2026
- EUDAMED a7bef557-2cca-41d3-b2b9-0a6c5a008191 61 fields · synced May 18, 2026
- EUDAMED ceddbd84-a699-48b5-8956-69b89f854bd2 61 fields · synced May 18, 2026
- EUDAMED f6d3ac35-806a-4235-9da7-9cd4fbdbcc25 61 fields · synced May 18, 2026
- EUDAMED acf726d2-1440-404b-b74d-d82e75010a30 61 fields · synced May 18, 2026
- FDA UDI d6e1419b-4ea9-4b1d-8491-2cd3ec058598 35 fields · synced May 30, 2026
- FDA UDI ac31c1c5-ad57-4b29-beb1-74187d196393 33 fields · synced May 30, 2026
- FDA UDI d943da93-2510-4ff2-9dc6-8ebe6b848cd9 35 fields · synced May 30, 2026
- FDA UDI 34827a0b-b612-43b2-ad74-2305e693af3d 34 fields · synced May 30, 2026
- EUDAMED 43e23cac-5e33-4bb8-8a25-3d809fcfc632 61 fields · synced Jul 10, 2026
- EUDAMED c3ad06d6-4e09-4842-a044-2e3ae82fef0f 61 fields · synced Jul 14, 2026
- EUDAMED 80f4d23a-8a7b-4e9a-ae08-a9d15a23dade 61 fields · synced Jul 14, 2026
- EUDAMED f050aa37-dcee-44d9-925d-248e92e7bc7c 61 fields · synced Jul 15, 2026
- EUDAMED 3830670a-34ef-47f9-86b8-d062da0de731 61 fields · synced Jul 29, 2026
- EUDAMED bd2892df-531b-4031-8352-164d3f5ed2a8 61 fields · synced Jul 30, 2026
- EUDAMED 04eb6726-b60a-4555-bb5b-8cfa6964dafd 61 fields · synced Aug 2, 2026