ELLAVI Drape
by SINAPI Biomedical (Pty) Ltd South Africa EUDAMED
Ref BC01
EMDN T0210
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number60099003867BC01M6 | Date4 Jun 2026 | StatusWithdrawn |
Coverage
- Withdrawn
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Model / Reference
- BC01
- Primary DI / UDI-DI
- 06009888639467
- Basic UDI-DI
- 60099003867BC01M6
- EMDN Code
- T0210 Non-surgical drapes
- Device Class
- Class I
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 (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
Sources (1)
- EUDAMED be62816f-0b72-4c60-bed6-076b5ee035c7