Identity
- Trade Name
- ColpotomizOR Tube System™ EUDAMEDColpotomizOR Tube System FDA UDI
- Generic Name
- Uterine manipulator, single-use FDA UDI
- Device Name
- Uterine Manipulator and Elevator (With or Without Tube for Trans-Vaginal Access) EUDAMED
- Model / Reference
- CTS35-TV EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 19349967004996 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670UTNMANPLTR58051BT EUDAMED
- FDA Product Code
- HEW 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
- 884.1640 FDA UDI
- Market of Registration
- Poland 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
Dimensions & Sizes
- Size
- Outer Diameter — 35 Millimeter FDA UDI
ColpotomizOR Tube System™ by The O R Company Pty Ltd — 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 | 93499670UTNMANPLTR58051BT | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED ac41f6c2-358f-4e96-b18f-51cf9a3470f4 61 fields · synced Jul 9, 2026
- FDA UDI 09dc97c5-91e1-4784-9aca-e64138e24c08 33 fields · synced May 30, 2026