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SpiroSafe Disposable Flow Transducers

EUDAMED

Class IIa (EU MDR)

Ref M9242-100Model M9242

Identity

Trade Name: SpiroSafe Disposable Flow Transducers EUDAMED
Device Name: Medikro® SpiroSafe Disposable Flow Transducer EUDAMED
Model / Reference: M9242 EUDAMED
M9242-100 EUDAMED

Identifiers

Primary DI / UDI-DI: D-M9242-10077 EUDAMED
Basic UDI-DI: B-M9242-10077 EUDAMED
EMDN Code: Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Finland EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Pulmonary function testing filter/mouthpiece

SpiroSafe Disposable Flow Transducers by Medikro Oy — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Pulmonary function testing filter/mouthpiece.

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer: Medikro Oy
EUDAMED SRN: FI-MF-000011841

Sources (1)

EUDAMED 8ca9912e-f465-4374-954d-1abcd177b2bc 61 fields · synced Jun 18, 2026