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ClearView Total Uterine Manipulator 9cm tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref UM950Model UM700
Identity
- Trade Name
- ClearView Total Uterine Manipulator 9cm tip EUDAMEDClearView Total Uterine Manipulator FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- ClearView Uterine Manipulator EUDAMEDClearView Total Uterine Manipulator, 9cm tip FDA UDI
- Model / Reference
- UM700 EUDAMEDUM950 EUDAMEDFDA UDI
- Description
- ClearView Total Uterine Manipulator, 9cm tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020611 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 9cm tip by Clinical Innovations, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0814247700900UM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED 719e22cd-7b8e-4380-9c51-fb7094aae64f 61 fields · synced Jul 23, 2026
- FDA UDI 6e0cf12e-6a26-4856-a285-aa184e9c762c 33 fields · synced May 30, 2026