Ellavi UBT
by SINAPI Biomedical (Pty) Ltd South Africa EUDAMED
Ref UBT-DModel UBT
EMDN U100102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number60099003902UBTUL | Date11 May 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- UBT, UBT-D
- Primary DI / UDI-DI
- 06009888639016
- Basic UDI-DI
- 60099003902UBTUL
- EMDN Code
- U100102 Postpartum intrauterine catheters
- Device Class
- Class IIa
- Market of Registration
- Spain
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 06009888639016|60099003902UBTUL