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ClearView Total Uterine Manipulator 7cm tip
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref UM750Model UM700
Identity
- Trade Name
- ClearView Total Uterine Manipulator 7cm tip EUDAMEDClearView Total Uterine Manipulator FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- ClearView Uterine Manipulator EUDAMEDClearView Total Uterine Manipulator, regular tip (7cm) FDA UDI
- Model / Reference
- UM700 EUDAMEDUM750 EUDAMEDFDA UDI
- Description
- ClearView Total Uterine Manipulator, regular tip (7cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020499 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247700900UM EUDAMED
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- Z120899 GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Colpotomy tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Italy 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
Yes
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
Yes
FDA UDI
ClearView Total Uterine Manipulator 7cm tip by Clinical Innovations, LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131781 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0814247700900UM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (3)
- EUDAMED 0429a6b6-9116-48b5-bf3c-15b94a9734e0 61 fields · synced Jun 19, 2026
- FDA UDI 6dd338a8-8a86-4e4e-89b9-5b293397a8c2 33 fields · synced May 29, 2026
- FDA 510(k) K131781 1 fields · synced May 18, 2026