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Insect Bite Healer

by AOJ HEALTH Technology Co., Ltd. 33 variants

Ref IBR 10Model IB 100, IB 200, IB 150, IB 80, IB A50, IB 50E, IBR10, IBR20, IBR30, IBR40, IBR50, IBR60, IBR600, IBR700, IBR800, IBR900, BR70, BR75, BR100, BR200, IB 50E, IBR70, IBR75, IBR80

Active European Union

CE MDR

Valid until

17 Mar 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

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 NumberFI24/1008006 Date7 Apr 2026IssuedStatusActive expires 17 Mar 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI24/1008006 Active Supplemented

    Quality management system EU MDR

    Certifier
    SGS FIMKO OY 0598
    Issued
    7 Apr 2026
    Expires
    17 Mar 2028
    Valid from
    8 Apr 2026
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
IB 100, IB 200, IB 150, IB 80, IB A50, IB 50E, IBR10, IBR20, IBR30, IBR40, IBR50, IBR60, IBR600, IBR700, IBR800, IBR900, BR70, BR75, BR100, BR200, IBR70, IBR75, IBR80, IBR 10
Primary DI / UDI-DI
06976313751455
Basic UDI-DI
697631375IBXTG
Direct Marketing DI
06976313751455
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class IIa
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000037449
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from AOJ HEALTH Technology Co., Ltd.

See all devices from AOJ HEALTH Technology Co., Ltd. →

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