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VersaVue™ Single-Use Flexible Cystoscope (Standard, box)
EUDAMEDClass IIa (EU MDR)
Ref M0067801000Model EUC 100
Identity
- Trade Name
- VersaVue™ Single-Use Flexible Cystoscope (Standard, box) EUDAMED
- Device Name
- VersaVue™ Single-Use Flexible Cystoscope EUDAMED
- Model / Reference
- EUC 100 EUDAMEDM0067801000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719872715047 EUDAMED
- Basic UDI-DI
- 47198727150018R EUDAMED
- Direct Marketing DI
- 04719872715047 EUDAMED
- EMDN Code
- Z12020701 CYSTOSCOPES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
VersaVue™ Single-Use Flexible Cystoscope (Standard, box) by Medimaging Integrated Solution Inc. — Class IIa — MDR — listed in EUDAMED
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 | 47198727150018R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medimaging Integrated Solution Inc
- EUDAMED SRN
- TW-MF-000009317
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED a05045d6-1673-4dff-8d2c-ee678565f280 61 fields · synced Jun 18, 2026