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Amielle Care

by Owen Mumford Ltd 3 variants

Ref SM2150EK015

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5016189AMIELLENU Basic UDI-DI 05016189115010UDI-DIDate7 Mar 2022RegisteredStatusActive

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  • Withdrawn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
Amielle
Model / Reference
SM2150EK015
Primary DI / UDI-DI
05016189115010
Basic UDI-DI
5016189AMIELLENU
EMDN Code
L0509020101 Vaginal dilators, reusable
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000021000
Authorised representative
Owen Mumford GmbH DE-AR-000020700

Other devices from Owen Mumford Ltd

See all devices from Owen Mumford 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