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Squishon 2, Gel Pillow (Case of 12)

by International Biomedical

Ref 989803196361Model BETTER BENDY BUMPER - 28IN

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00850018561068 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0850018561POSITION3H Basic UDI-DI 00850018561068UDI-DIDate30 May 2026RegisteredStatusActive

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.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Squishon 2, Gel Pillow (Case of 12) EUDAMED
Squishon GUDID
Generic Name
Flotation therapy bed, neonatal
Device Name
Positioning Aid Products
Model / Ref / Catalog
BETTER BENDY BUMPER - 28IN, 989803196361, Squishon 2 Gel Pillow, 12/pk
Primary DI / UDI-DI
00850018561068
Basic UDI-DI
0850018561POSITION3H
Direct Marketing DI
00850018561068
FDA Product Code
FMP
EMDN Code
V0810 Newborn positioners
GMDN Term
Flotation therapy bed, neonatal
Device Class
Class I
Regulation Number
880.6450
EU 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
989803196361
GUDID
Squishon 2 Gel Pillow, 12/pk

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