Identity
- Trade Name
- VersaVue™ Tablet EUDAMEDVersaVue Tablet - Global/CE FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- VersaVue™ Single-Use Flexible Cystoscope EUDAMEDVersaVue Tablet - Global/CE The VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor. FDA UDI
- Model / Reference
- EUC 100 EUDAMEDM0067805100 EUDAMED5015 FDA UDI
- Description
- VersaVue Tablet - Global/CE The VersaVue™ Tablet and VersaVue™ Video Box are plug-and-play visualization modules that are used with disposable VersaVue™ Cystoscopes to project images onto a monitor. FDA UDI
Identifiers
- Catalog Number
- M0067805100 FDA UDI
- Primary DI / UDI-DI
- 04719872715313 EUDAMEDFDA UDI
- Basic UDI-DI
- 47198727150018R EUDAMED
- Direct Marketing DI
- 04719872715313 EUDAMED
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020780 GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Flexible video cystoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rigid endoscope obturator
VersaVue™ Tablet by Medimaging Integrated Solution Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47198727150018R | Class IIa | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (3)
- EUDAMED 65b839ea-d133-4ec8-8829-d29812ae99e6 61 fields · synced Jul 20, 2026
- FDA UDI 3d6e2cd8-d31d-4db3-8357-8b69f79a27bd 34 fields · synced May 29, 2026
- EUDAMED 46cb2f23-9bcb-41c5-86da-12fa4f5cc4e2 61 fields · synced Jul 20, 2026