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Pack Knee Replacement

by Unisurge International Ltd

Ref F601384.B

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5053488F6QX Basic UDI-DI 05053488000111UDI-DIDate19 May 2023RegisteredStatusActive

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  • Withdrawn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
F6 Product Family - Procedure Packs Used For Orthopaedic Procedures
Model / Reference
F601384.B
Primary DI / UDI-DI
05053488000111
Basic UDI-DI
5053488F6QX
EMDN Code
T0202 Surgical procedural kits (excluding surgical instrument kits)
Device Class
Class I
Medical Purpose
Procedure Pack

Manufacturer details

EUDAMED SRN
GB-PR-000033353

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Properties

  • Sterile