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MAST® CARBA PAcE

by Mast Group Limited

Ref PACE-ID

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-PACEIDFD Basic UDI-DI D-PACEIDFDUDI-DIDate7 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
PACE-ID
Primary DI / UDI-DI
D-PACEIDFD
Basic UDI-DI
B-PACEIDFD
EMDN Code
W0104080506 Targeted resistance tests - carbapenemase
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000025209
Authorised representative
Mast Diagnostica GmbH DE-AR-000005299

Other devices from Mast Group, Ltd.

See all devices from Mast Group, Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No