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Prone Plus - Extra Small

by International Biomedical

Ref 989805604811Model BETTER BENDY BUMPER - 28IN

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 Number0850018561POSITION3H Basic UDI-DI 00850018561419UDI-DIDate30 May 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  • Withdrawn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
Positioning Aid Products
Model / Reference
BETTER BENDY BUMPER - 28IN, 989805604811
Primary DI / UDI-DI
00850018561419
Basic UDI-DI
0850018561POSITION3H
Direct Marketing DI
00850018561419
EMDN Code
V0810 Newborn positioners
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000017330
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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