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DE609

by Firefly Global

Ref DE609

DE609 is a Class I device made by Firefly Global, registered in EUDAMED on 9 Apr 2026 (Basic UDI-DI 0851289007DE609QY), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0851289007DE609QY Basic UDI-DI 00851289007361UDI-DIDate9 Apr 2026RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
DE609
Primary DI / UDI-DI
00851289007361
Basic UDI-DI
0851289007DE609QY
Direct marketing DI
00851289007361
EMDN code
Z12040199 General medicine diagnosis and monitoring instruments - other
Device class
Class I
EU registration type
Standard device
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
US-MF-000020015
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - OTHER.

Other devices from Firefly Global

See all devices from Firefly Global →

Properties

Other properties (14, all answered No)