Skip to content

SPECTRA Handsfree Breast Shield Set 2

by Uzinmedicare

Model Breast Pump Accessories

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 Number880910801SPAc001R3 Basic UDI-DI 08809108019639UDI-DIDate11 Jun 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  • Withdrawn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
Breast Pump Accessories
Model / Reference
Breast Pump Accessories
Primary DI / UDI-DI
08809108019639
Basic UDI-DI
880910801SPAc001R3
EMDN Code
Z12080380 Various childbirth support and maternal assistance instruments - hardware accessories
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000031282
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Uzinmedicare

See all devices from Uzinmedicare →

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