Skip to content

Gel-E Donut, Medium (Case of 12)

by International Biomedical EUDAMEDGUDID

Active European Union

Ref 989803196391Model BETTER BENDY BUMPER - 28IN

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850018561037 UDI-DIDate13 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850018561POSITION3H Basic UDI-DIDate30 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Gel-E Donut, Medium (Case of 12) EUDAMED
Gel-E Donut GUDID
Generic Name
Flotation therapy bed, neonatal
Device Name
Positioning Aid Products
Model / Ref / Catalog
BETTER BENDY BUMPER - 28IN, 989803196391, GEL-E DONUT, MEDIUM (CASE OF 12)
Primary DI / UDI-DI
00850018561037
Basic UDI-DI
0850018561POSITION3H
Direct Marketing DI
00850018561037
FDA Product Code
FMP
EMDN Code
V0810 Newborn positioners
GMDN Term
Flotation therapy bed, neonatal
Device Class
Class I
Regulation Number
880.6450
Market of Registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
BETTER BENDY BUMPER - 28IN
989803196391
GUDID
GEL-E DONUT, MEDIUM (CASE OF 12)

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

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No