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Class I Instruments

by Ortho Solutions UK Ltd

Ref OS328010Model Non-Invasive Devices and Accessories

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50556629257M Basic UDI-DI 05055662923605UDI-DIDate12 Jun 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Class I Instruments
Model / Reference
Non-Invasive Devices and Accessories, OS328010
Primary DI / UDI-DI
05055662923605
Basic UDI-DI
50556629257M
Direct Marketing DI
05055662923605
EMDN Code
S010401 Trays, baskets, tubs for sterilisation and their components
Device Class
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000030101
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Ortho Solutions UK Limited

Properties

  • Reusable

Other properties (12)

  • Sterile: No
  • Implantable: 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