Is this your brand? Sign in to claim ownership.
Sign in to claim this brandSURGI SUPPLIES INTERNATIONAL PTY. LTD.
US
Last updated May 30, 2026
What SURGI SUPPLIES INTERNATIONAL PTY. LTD. makes
The company manufactures single-use colpotomy tubes and uterine manipulators, including systems combining both devices. These are designed for surgical procedures involving the uterus, such as hysteroscopy or laparoscopic interventions.
The portfolio consists of Class II medical devices, all listed in the FDA’s Unique Device Identification (UDI) system. The company operates from the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does SURGI SUPPLIES INTERNATIONAL PTY. LTD. manufacture?
SURGI SUPPLIES INTERNATIONAL PTY. LTD. specializes in single-use medical devices primarily used in gynecological surgeries. Their portfolio includes colpotomy tubes and uterine manipulators, as well as systems that combine these devices. These tools are designed to assist in procedures like hysteroscopy or laparoscopic interventions involving the uterus.
Where is SURGI SUPPLIES INTERNATIONAL PTY. LTD. based?
The company is based in the United States. This location allows them to operate within the regulatory framework of the FDA, which is relevant given their device classifications and compliance requirements.
Which regulatory registries or databases list the devices manufactured by SURGI SUPPLIES INTERNATIONAL PTY. LTD.?
The devices produced by SURGI SUPPLIES INTERNATIONAL PTY. LTD. are listed in the FDA’s Unique Device Identification (UDI) system. This system is used to track and identify medical devices throughout their distribution and use lifecycle, ensuring traceability and regulatory compliance.
How are the devices manufactured by SURGI SUPPLIES INTERNATIONAL PTY. LTD. classified under regulatory standards?
All devices manufactured by SURGI SUPPLIES INTERNATIONAL PTY. LTD. fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 753476779
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ColpotomizOR Tube | 45mm | FDA UDI | Class II | Active |
| ColpotomizOR Tube | 35mm | FDA UDI | Class II | Active |
| ColpotomizOR Tube System | 45mm | FDA UDI | Class II | Active |
| ManipulatOR | UM-TV | FDA UDI | Class II | Active |
| ColpotomizOR Tube System | 35mm | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.