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Amplidiag C. difficile+027 Calibration Kit

EUDAMED

Class IVD General (EU MDR)

Ref AD-CDCS-30

by Mobidiag Ltd.

Identity

Trade Name
Amplidiag C. difficile+027 Calibration Kit EUDAMED
Device Name
Amplidiag C. difficile+027 Calibration Kit EUDAMED
Model / Reference
AD-CDCS-30 EUDAMED

Identifiers

Primary DI / UDI-DI
06430041761549 EUDAMED
Basic UDI-DI
B-06430041761549 EUDAMED
EMDN Code
W01040699 CONTROLS, STANDARDS, CALIBRATORS, MICROBIOLOGY - OTHER EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Multiple bacteria species culture isolate identification control IVD, kit

Amplidiag C. difficile+027 Calibration Kit by Mobidiag Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Multiple bacteria species culture isolate identification control IVD, kit.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union No Longer Active

CE/IVDD

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Manufacturer

Manufacturer
Mobidiag Ltd.
EUDAMED SRN
FI-MF-000001215

Sources (1)

  • EUDAMED 371b286e-96c5-42f9-8cf9-f5acbd5f9304 61 fields · synced Jul 15, 2026