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Revitive Aerosure

by Actegy Limited

Ref 3481AJ

Revitive Aerosure (3481AJ) is a medical device (EU MDR Class I; EMDN category respiratory tract expansion systems - accessories) made by Actegy Limited, registered in EUDAMED on 25 May 2026 (Basic UDI-DI 5060217493481AJDD), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5060217493481AJDD Basic UDI-DI 50602174934812UDI-DIDate25 May 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  • Withdrawn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
3481AJ
Primary DI / UDI-DI
50602174934812
Basic UDI-DI
5060217493481AJDD
EMDN code
R050280 Respiratory tract expansion systems - accessories
Device class
Class I
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000032543
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

Other devices filed under SUCTION AND DILATATION SYSTEMS FOR THE RESPIRATORY SYSTEM.

Other devices from Actegy Limited

See all devices from Actegy Limited →

Properties

Other properties (14, all answered No)