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Sanctband™ Active Loop Band - Pink

by Sanctuary Health Sdn Bhd

Ref LB002P-DASA0

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number955551400LBSH01CH Basic UDI-DI 09555514006204UDI-DIDate14 Oct 2026RegisteredStatusActive

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  • Withdrawn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
SanctbandTM/ Sanctband ActiveTM Loop Band
Model / Reference
LB002P-DASA0
Primary DI / UDI-DI
09555514006204
Basic UDI-DI
955551400LBSH01CH
Direct Marketing DI
09555514006204
EMDN Code
Y0599 Learning and training devices - other
Device Class
Class I
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
MY-MF-000002197
Authorised representative
cosiMed GmbH DE-AR-000016444

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Properties

  • Contains Latex

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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