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ClearView Uterine Manipulator 9cm tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref UM900Model UM700
Identity
- Trade Name
- ClearView Uterine Manipulator 9cm tip EUDAMEDClearView Uterine Manipulator FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- ClearView Uterine Manipulator EUDAMEDClearView Uterine Manipulator, 9cm FDA UDI
- Model / Reference
- UM700 EUDAMEDUM900 EUDAMEDFDA UDI
- Description
- ClearView Uterine Manipulator, 9cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020604 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247700900UM EUDAMED
- 510(k) Number
- K940681 FDA UDI
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- Z120899 GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Uterine manipulator, single-use 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
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 Uterine Manipulator 9cm tip by Clinical Innovations, LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 6b3f2b34-4d29-4cf7-84f7-b8631caddb95 61 fields · synced Jun 19, 2026
- FDA UDI ed1a94a4-85ea-4387-96a5-8e42d825c176 34 fields · synced May 30, 2026