Trocar kit
by Unimicro Medical Systems (Shenzhen) Co., Ltd United States EUDAMED
Ref UNTB-RD1210
EMDN K01010102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-06955797766148 | Date24 Oct 2025 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/MDD Expiring (legacy directive)
Specification
- Device Name
- Hasson Balloon Trocar
- Model / Reference
- UNTB-RD1210
- Primary DI / UDI-DI
- 06955797766148
- Basic UDI-DI
- B-06955797766148
- EMDN Code
- K01010102 Hasson trocar, single-use
- Device Class
- Class IIa
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000014590
- Authorised representative
- Wellkang Ltd XI-AR-000001836
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Properties & raw data
Show properties, registry sources and raw records
Other properties (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED c784fdd9-0c16-47d7-aee8-717dd5ca35cb