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Amplidiag Easy Process Control II

EUDAMED

Class IVD General (EU MDR)

Ref AE-RC803x8

by Mobidiag Ltd.

Identity

Trade Name
Amplidiag Easy Process Control II EUDAMED
Device Name
Amplidiag Easy Process Control II EUDAMED
Model / Reference
AE-RC803x8 EUDAMED

Identifiers

Primary DI / UDI-DI
06430041761150 EUDAMED
Basic UDI-DI
B-06430041761150 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 Easy Process Control II 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European Union No Longer Active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 776ecc88-a3fb-4538-84a9-265bfeee1012 61 fields · synced Jun 18, 2026