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MEDiaPure™ UF40 FLAT - EO

by Medica S.p.A.

Part of a family of 14 devices: see the family page

Ref M90380

MEDiaPure™ UF40 FLAT - EO (M90380) is a Class IIa device made by Medica S.p.A., registered in EUDAMED on 2 Jul 2026 (Basic UDI-DI 803377232ULT-RWOSP) with CE/MDR certificate MDR 00048-A valid until 31 May 2028, active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

31 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803377232ULT-RWOSP Basic UDI-DI 08033772328920UDI-DIDate2 Jul 2026RegisteredStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 00048-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    16 Apr 2026
    Expires
    31 May 2028

Timeline

3 dated events

  1. Certificate issued EUDAMED MDR 00048-A
  2. Registered EUDAMED 803377232ULT-RWOSP
  3. Certificate expires EUDAMED MDR 00048-A

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Ultrafiltration Devices for Purified Water for Reverse Osmosis
Model / reference
M90380
Primary DI / UDI-DI
08033772328920
Basic UDI-DI
803377232ULT-RWOSP
EMDN code
F01080201 Endotoxin removal filters
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000025691

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Properties

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