Identity
- Trade Name
- ColpotomizOR Tube™ EUDAMEDColpotomizOR Tube FDA UDI
- Generic Name
- Colpotomy tube FDA UDI
- Device Name
- Tube for Trans-Vaginal Access EUDAMED
- Model / Reference
- C35-TV EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09349967002575 EUDAMEDFDA UDI
- Basic UDI-DI
- 93499670TRNSVGNLTB47936MM EUDAMED
- FDA Product Code
- HEW FDA UDI
- EMDN Code
- U0899 GYNAECOLOGICAL DEVICES - OTHER EUDAMED
- GMDN Term
- Colpotomy tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1640 FDA UDI
- Market of Registration
- Türkiye 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 — 32 Millimeter FDA UDI
ColpotomizOR Tube™ 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 | 93499670TRNSVGNLTB47936MM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The O R Company Pty Ltd
- EUDAMED SRN
- AU-MF-000010179
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 341dd843-c361-415e-b072-d10d9ac04295 61 fields · synced Jun 19, 2026
- FDA UDI c4d71653-467d-4ca9-970f-29b8d24c4a0b 33 fields · synced May 30, 2026