Opencast
by OPENCAST inc. EUDAMED
Withdrawn
Ref 3Model CM-03, CM-04, CM-05, CM-06, CM-07, CM-08, SA-S, SA-M, SA-L, LA-S, LA-M, LA-L, SL-S, SL-M, SL-L
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number88001098OMBT | Date21 Apr 2022 | StatusWithdrawn |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Withdrawn
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Opencast
- Model / Reference
- CM-03, CM-04, CM-05, CM-06, CM-07, CM-08, SA-S, SA-M, SA-L, LA-S, LA-M, LA-L, SL-S, SL-M, SL-L, 3
- Primary DI / UDI-DI
- 08800109800004
- Basic UDI-DI
- 88001098OMBT
- EMDN Code
- M03050202 Synthetic cast bandages and splints
- Device Class
- Class I
Manufacturer details
- EUDAMED SRN
- KR-MF-000011553
- Authorised representative
- Javitech Consulting GmbH DE-AR-000045915
Other devices from OPENCAST inc.
Properties
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