FSR445-311515 Low vacuum suction controller mounted on a direct BS probe
by Gabler Medical (Pty) Ltd EUDAMED
Active
Ref FSR445-311515Model Suction Equipment Powered by a Pressure Source
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number6009526100007GMTF02RB | Date1 Jul 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Suction Equipment Powered by a Pressure Source
- Model / Reference
- Suction Equipment Powered by a Pressure Source, FSR445-311515
- Primary DI / UDI-DI
- 06009526128209
- Basic UDI-DI
- 6009526100007GMTF02RB
- EMDN Code
- A0601010201 Drainage systems with adjustable suction and collection chamber
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- ZA-MF-000046864
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Gabler Medical (Pty) Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No