SC04FGC
Part of a family of 41 devices: see the family page
Ref SC04FGCModel SteriTite
SC04FGC is a medical device (EU MDR Class I; EMDN category trays) made by Case Medical Inc, registered in EUDAMED on 27 Aug 2026 (Basic UDI-DI 0653159SC0001PB7M), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0653159SC0001PB7M 00653159016134 | Date27 Aug 2026 | StatusActive |
Official records
- EUDAMED public site 0653159SC0001PB7M
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- SC02MGC
- Model / reference
- SteriTite, SC04FGC
- Primary DI / UDI-DI
- 00653159016134
- Basic UDI-DI
- 0653159SC0001PB7M
- Direct marketing DI
- 00653159016134
- EMDN code
- S010401 Trays, baskets, tubs for sterilisation and their components
- Device class
- Class I
- System or procedure pack
- System which is a device in itself
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- US-MF-000036357
- Authorised representative
- MDSS GmbH DE-AR-000005430
Similar devices in this category
Other devices filed under TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS.
- PST Corp. 2600L by Plastic Sterilizing Tray Corporation
- PST Corp. 6509S by Plastic Sterilizing Tray Corporation
- Surgery Kit Standard Hex - Plastic Tray MIH6312 by MEDIGMA BIOMEDICAL GMBH
- The Simple Locking Intra Medullary System BLT-CSE100 by ORTHOPEDIATRICS CANADA ULC
- Stryker Universal Select Sterilization Tray System by Paragon Medical Inc.