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Amplidiag Easy Process Control I

EUDAMED

Class IVD General (EU MDR)

Ref AE-RC802x8

by Mobidiag Ltd.

Identity

Trade Name
Amplidiag Easy Process Control I EUDAMED
Device Name
Amplidiag Easy Process Control I EUDAMED
Model / Reference
AE-RC802x8 EUDAMED

Identifiers

Primary DI / UDI-DI
06430041761143 EUDAMED
Basic UDI-DI
B-06430041761143 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 I 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European Union No Longer Active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 220f2420-e289-40e8-ab97-0cf056b2d8a2 61 fields · synced Jun 19, 2026