RebiSmart
by Ares Trading SA Switzerland EUDAMED
Ref U6711169
EMDN A99
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4054839RebiSmart30LE | Date23 Jan 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- RebiSmart 3.0
- Model / Reference
- U6711169
- Primary DI / UDI-DI
- 04065268544952
- Basic UDI-DI
- 4054839RebiSmart30LE
- Direct Marketing DI
- 04065267320601
- EMDN Code
- A99 Devices for administration, withdrawal and collection - other
- Device Class
- Class IIa
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- CH-MF-000021799
- Authorised representative
- Merck Healthcare KGaA DE-AR-000007181
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- 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
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 906e5f74-f137-4b66-9027-91f0a4911bcb