SCFM01-5
by Case Medical Inc EUDAMED
Active
Ref SCFM01-5Model SteriTite
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0653159SC0001GV82 | Date12 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Dpy-SCF01
- Model / Reference
- SteriTite, SCFM01-5
- Primary DI / UDI-DI
- 00653159011429
- Basic UDI-DI
- 0653159SC0001GV82
- Direct Marketing DI
- 00653159011429
- EMDN Code
- S010402 Filters for sterilisation containers
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000036357
- Authorised representative
- MDSS GmbH DE-AR-000005430
Other devices from Case Medical 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