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Otopore

by Stryker Instruments 3 variants

Ref 5400-020-100ITLModel 08858251002248SQ

Otopore (5400-020-100ITL) is a Class I device made by Stryker Instruments, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 08858251002248SQ), active as of 7 Nov 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08858251002248SQ Basic UDI-DI 07613327359497UDI-DIDate27 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
08858251002248SQ, 5400-020-100ITL
Primary DI / UDI-DI
07613327359497
Basic UDI-DI
08858251002248SQ
EMDN code
Q030499 Otology devices - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000025219
Authorised representative
Stryker European Operations Limited IE-AR-000000092

Similar devices in this category

Other devices filed under OTOLOGY DEVICES - OTHER.

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Properties

  • Supplied sterile
Other properties (13, all answered No)