Mentype AMLplex PCR Amplification Kit

by BIOTYPE GmbH 3 variants

Ref 45-12100-0400

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number42519352AMLPLEXPCRAMKITJG Basic UDI-DI	Date3 Sep 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference: 45-12100-0400

Primary DI / UDI-DI: 04251935200720
Basic UDI-DI: 42519352AMLPLEXPCRAMKITJG
EMDN Code: W010699 Genetic tests - other

Device Class: Class C
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: DE-MF-000025906

From the manufacturer

Manufacturer's product page: Mentype® AMLplexQS PCR Amplification Kit

Other devices from BIOTYPE GmbH

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Class C
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Class C
Mentype DIPscreen PCR Amplification Kit

Class C
Matrix Standard BT5 multi

Class A
Mentype Chimera PCR Amplification Kit

Class C

See all devices from BIOTYPE GmbH →

Properties

Animal Tissues
Reagent
Professional Testing

Other properties (8)

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