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Better Bendy Bumper - 28IN

by International Biomedical Switzerland EUDAMED

Ref 989805604581Model BETTER BENDY BUMPER - 28IN EMDN V0810

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850018561POSITION3H Basic UDI-DIDate30 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Positioning Aid Products
Model / Reference
BETTER BENDY BUMPER - 28IN, 989805604581
Primary DI / UDI-DI
00850018561501
Basic UDI-DI
0850018561POSITION3H
Direct Marketing DI
00850018561501
EMDN Code
V0810 Newborn positioners
Device Class
Class I
Market of Registration
Austria

Manufacturer details

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

Other devices from International Biomedical, Ltd.

See all devices from International Biomedical, Ltd. →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED c5ae8e56-ccb3-4b7e-bc6f-3c6c4020f344 61 fields · synced 24 Oct 2026