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Disposable Sound - Dilator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref DSD-1000Model UM700
Identity
- Trade Name
- Disposable Sound - Dilator EUDAMEDClearView FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- ClearView Uterine Manipulator EUDAMEDSound/Dilator (accessory for ClearView Uterine Manipulator) FDA UDI
- Model / Reference
- UM700 EUDAMEDDSD-1000 EUDAMEDFDA UDI
- Description
- Sound/Dilator (accessory for ClearView Uterine Manipulator) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020130 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
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
Disposable Sound - Dilator 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 315b1e88-57d2-4a59-a594-30477600f2af 61 fields · synced Jul 17, 2026
- FDA UDI d2a9594f-82ef-4bf8-a01a-c1862c391ca8 34 fields · synced May 30, 2026