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Spiro Lenis

by Jnbio

Ref PRD-LS-001Model SL503

Spiro Lenis (PRD-LS-001) is a medical device (EU MDR Class IIa; EMDN category clinical/diagnostic spirometers) made by Jnbio, registered in EUDAMED on 26 Jan 2026 (Basic UDI-DI B-08800184100006), active as of 22 Oct 2026.

Active European Union

CE MDR CE MDD

Valid until

No date given

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

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-08800184100006 Basic UDI-DI 08800184100006UDI-DIDate26 Jan 2026RegisteredStatusActive
European UnionCE/MDD NumberB-08800184100006 Basic UDI-DI 08800184100006UDI-DIDate26 Jan 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR, CE/MDD Active

Specification

EUDAMED

Model / reference
SL503, PRD-LS-001
Primary DI / UDI-DI
08800184100006
Basic UDI-DI
B-08800184100006, 8800184SPIRO54
EMDN code
Z12150101 Clinical/diagnostic spirometers
Device class
Class IIa
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
KR-MF-000042575
Authorised representative
Javitech Consulting GmbH DE-AR-000045915

Similar devices in this category

Other devices filed under CLINICAL/DIAGNOSTIC SPIROMETERS.

Properties

  • Measuring function
Other properties (13, all answered No)