Identity
- Trade Name
- DUMI ManipulatOR™ EUDAMEDDUMI ManipulatOR FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Uterine Manipulator and Elevator (With or Without Tube for Trans-Vaginal Access) EUDAMEDDiagnostic Uterine Manipulator Injector FDA UDI
- Model / Reference
- DUMI-350A EUDAMEDFDA UDI
- Description
- Diagnostic Uterine Manipulator Injector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349967001028 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670UTNMANPLTR58051BT EUDAMED
- FDA Product Code
- LKF FDA UDI
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - 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
- France 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
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
No
FDA UDI
DUMI ManipulatOR™ by The O R Company Pty Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K212505 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 93499670UTNMANPLTR58051BT | Class IIa | Active |
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Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- EUDAMED SRN
- AU-MF-000010179
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 625632f3-cac2-4a3d-92d5-becb652ddef2 61 fields · synced Jul 14, 2026
- FDA UDI 20688f6e-8f65-4329-bc88-0166b04b5ea0 33 fields · synced May 30, 2026
- FDA 510(k) K212505 1 fields · synced May 18, 2026