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Baby Shell

by Inside Creation 4 variants

Ref BS-XLModel Baby Shell – Coquillages d’allaitement

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 Number3770015563BS-COQALFZ Basic UDI-DI 03770015563834UDI-DIDate13 Jan 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  • Withdrawn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
Baby Shell – Coquillages d’allaitement
Model / Reference
Baby Shell – Coquillages d’allaitement, BS-XL
Primary DI / UDI-DI
03770015563834
Basic UDI-DI
3770015563BS-COQALFZ
EMDN Code
Z12080399 Various childbirth support and maternal assistance instruments - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000050348

Other devices from Inside Creation

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