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Sterisafe

by Fapomed- Dispositivos Médicos, S.A. 4 variants

Ref 612471

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 Number56009615PP2017745223BV Basic UDI-DI 05600961551136UDI-DIDate3 Sep 2025RegisteredStatusActive

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  • Withdrawn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
System and Procedure Pack
Model / Reference
612471
Primary DI / UDI-DI
05600961551136
Basic UDI-DI
56009615PP2017745223BV
EMDN Code
V0599 Clinical procedures kits not included in other classes - other
Device Class
Class IIa
Medical Purpose
Systems and Procedure Packs are combinations of products packaged together and placed on the market with the intention of being used for a specific medical purpose.

Manufacturer details

EUDAMED SRN
PT-PR-000004889

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Properties

  • Sterile