SC03NGC
Part of a family of 41 devices: see the family page
Ref SC03NGCModel SteriTite
SC03NGC is a Class I device made by Case Medical Inc, registered in EUDAMED on 27 Aug 2026 (Basic UDI-DI 0653159SC0001PB7M), active as of 23 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 00653159005992 | 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- Withdrawn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, SC03NGC
- Primary DI / UDI-DI
- 00653159005992
- Basic UDI-DI
- 0653159SC0001PB7M
- Direct marketing DI
- 00653159005992
- 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
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- PST Corp. 6130A by Plastic Sterilizing Tray Corporation
- 5407-476-000 by Stryker Corp.
- Instrument tray 400460 by Si-Bone Inc.
- The Fassier-Duval Telescopic IM System FD-PEG-CEM-24 by ORTHOPEDIATRICS CANADA ULC
- The Free Gliding SCFE Screw System SCF-CCE130 by ORTHOPEDIATRICS CANADA ULC