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WiScope
EUDAMEDClass IIa (EU MDR)
Ref OTU-RL01Model OTU-RL01, OTU-RL02, OTU-RL03
Identity
- Trade Name
- WiScope EUDAMED
- Device Name
- Single-Use Digital Flexible Rhino-Laryngoscope EUDAMED
- Model / Reference
- OTU-RL01, OTU-RL02, OTU-RL03 EUDAMEDOTU-RL01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850023925350 EUDAMED
- Basic UDI-DI
- 0850023925009RV EUDAMED
- EMDN Code
- Z12021005 NASAL PHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
WiScope by Otu Medical Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850023925009RV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Otu Medical Inc.
- EUDAMED SRN
- US-MF-000020690
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 678e36d1-acba-439d-a3a8-e688ffd41504 61 fields · synced May 23, 2026