Skip to content

Medikro Pro

by Medikro Oy

Ref M915Model M9488

Medikro Pro (M915) is a diagnostic spirometer (EU MDR Class IIa; FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Medikro Oy, registered in EUDAMED on 20 May 2025 (Basic UDI-DI 6420099M9488LV) and listed in FDA GUDID since 13 Jul 2018 (UDI-DI 06420099000837), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6420099M9488LV Basic UDI-DI 06420099000837UDI-DIDate20 May 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number06420099000837 UDI-DI Date13 Jul 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 6420099M9488LV registered 20 May 2025 Active
  • FDA GUDID UDI-DI 06420099000837 listed 13 Jul 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06420099000837
  2. Registered EUDAMED 6420099M9488LV

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Medikro Pro EUDAMED
M915, Medikro® Pro GUDID
Generic name
Diagnostic spirometer, professional
Model / reference
M9488, M915
Primary DI / UDI-DI
06420099000837
Basic UDI-DI
6420099M9488LV
Direct marketing DI
06420099000837
FDA product code
BZG
EMDN code
Z12150101 Clinical/diagnostic spirometers
GMDN term
Diagnostic spirometer, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.1840
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
FI-MF-000011841

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

Other devices from Medikro Oy

See all devices from Medikro Oy →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)