Wound drainage system; Drenážní systém pro hojení ran
by BISMED, s.r.o. Czech Republic EUDAMED
Ref 05.000.22.802Model Vacuum bottle for wound drainage Redon with tube; Podtlaková lahev pro drenáž Redon s hadicí
EMDN A0601010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-024/A | Date3 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-024/A Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 3 Mar 2026
- Expires
- 25 Mar 2030
Specification
- Device Name
- Wound drainage system; Drenážní systém pro hojení ran
- Model / Reference
- Vacuum bottle for wound drainage Redon with tube, Podtlaková lahev pro drenáž Redon s hadicí, 05.000.22.802
- Primary DI / UDI-DI
- 18594199790051
- Basic UDI-DI
- 859419979REDONXH
- EMDN Code
- A0601010101 Drainage systems with redon type rigid container
- Models / Variants
- Device Class
- Class IIa
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000040871
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- 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
Sources (1)
- EUDAMED 3d5ba95b-3f49-422f-8289-cc96039fd978