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everActive

by Baltrade spółka z ograniczoną odpowiedzialnością 2 variants

Ref PR44/675, PR48/13, PR41/312, PR70/10

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number590320577ultrasonicAX Basic UDI-DI Date29 Sep 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
everActive Ultrasonic
Model / Reference
PR44/675, PR48/13, PR41/312, PR70/10
Primary DI / UDI-DI
05902020523185, 05902020523161, 05902020523178, 05902020523154
Basic UDI-DI
590320577ultrasonicAX
Direct Marketing DI
05902020523185
05902020523161
05902020523178
05902020523154
EMDN Code
Y214580 Hearing aids or hearing devices - accessories
Device Class
Class I
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
PL-MF-000038364

Other devices from Baltrade spółka z ograniczoną odpowiedzialnością

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No