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VersaVue™ Single-Use Flexible Cystoscope (Standard, single pack)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref M0067801010Model EUC 100
Identity
- Trade Name
- VersaVue™ Single-Use Flexible Cystoscope (Standard, single pack) EUDAMEDVersaVue™ FDA UDI
- Generic Name
- Flexible video cystoscope, single-use FDA UDI
- Device Name
- VersaVue™ Single-Use Flexible Cystoscope EUDAMEDVersaVue - Standard Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults. FDA UDI
- Model / Reference
- EUC 100 EUDAMEDM0067801010 EUDAMED5008 FDA UDI
- Description
- VersaVue - Standard Deflection Scope Single The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system. The device provides endoscopic visualization to aid in diagnosis and treatment within the lower urinary tract. The Cystoscope is intended to provide visualization via displaying unit. The Cystoscope is intended for use in a hospital environment. It is designed for use in adults. FDA UDI
Identifiers
- Catalog Number
- M0067801010 FDA UDI
- Primary DI / UDI-DI
- 04719872715146 EUDAMEDFDA UDI
- Basic UDI-DI
- 47198727150018R EUDAMED
- FDA Product Code
- FAJ FDA UDI
- EMDN Code
- Z12020701 CYSTOSCOPES 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
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
VersaVue™ Single-Use Flexible Cystoscope (Standard, single pack) by Medimaging Integrated Solution Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA…
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 (2)
- EUDAMED f84667ce-8582-4ff9-9351-fd131205ed50 61 fields · synced Jun 18, 2026
- FDA UDI c912f1ae-920f-4e12-a827-9472a62fb74b 35 fields · synced May 30, 2026