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HELPie

by Medrian Oy 6 variants

Ref 435743555, 43574355667, 435743575, 435743755, 435743775, 43574375667, 43574365667

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6429810828435743N8 Basic UDI-DI Date14 Mar 2022RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
HELPie Biteblock-Tongue cone-Saliva suction
Model / Reference
435743555, 43574355667, 435743575, 435743755, 435743775, 43574375667, 43574365667
Primary DI / UDI-DI
06429810828057, 06429810828118, 06429810828040, 06429810828019, 06429810828002, 06429810828071, 06429810828095
Basic UDI-DI
6429810828435743N8
Direct Marketing DI
06429810828057
06429810828118
06429810828040
06429810828019
06429810828002
06429810828071
06429810828095
EMDN Code
Q010599 Dental instruments, single-use - other
Device Class
Class I
EU market of registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000020407

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