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SC05NL

by Case Medical Inc

Part of a family of 24 devices: see the family page

Ref SC05NLModel SteriTite

SC05NL is a Class I device made by Case Medical Inc, registered in EUDAMED on 3 Sep 2026 (Basic UDI-DI 0653159SC0001SAG), active as of 25 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0653159SC0001SAG Basic UDI-DI 00653159012730UDI-DIDate3 Sep 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
SC02M
Model / reference
SteriTite, SC05NL
Primary DI / UDI-DI
00653159012730
Basic UDI-DI
0653159SC0001SAG
Direct marketing DI
00653159012730
EMDN code
S010499 Sterilisation containers - other
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 CONTAINERS FOR STERILISATION.

Other devices from Case Medical Inc

See all devices from Case Medical Inc →

Properties

Other properties (14, all answered No)