Sinapi Chest Drain
by SINAPI Biomedical (Pty) Ltd South Africa EUDAMED
Ref XL2000SModel XL1000+
EMDN A060203
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number60099003867SCDW5 | Date5 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- XL1000+, XL2000S
- Primary DI / UDI-DI
- 06009900390208
- Basic UDI-DI
- 60099003867SCDW5
- EMDN Code
- A060203 Pleural drainages with valve and kits
- Device Class
- Class I
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- ZA-MF-000012126
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from Sinapi Biomedical (Pty), Ltd.
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 1fe8bb6c-cb11-4031-b67e-991d96067671