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Universal Prone | Lower Body | Large

by Bone Foam, Inc.

Ref 925.UPS-L-LB

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081007528925UPSLLB9L Basic UDI-DI 00810075281262UDI-DIDate16 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810075281262 UDI-DI Date12 Jun 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Universal Prone | Lower Body | Large EUDAMED
BoneFoam GUDID
Generic Name
Operating table patient positioning set, reusable
Model / Ref / Catalog
925.UPS-L-LB
Primary DI / UDI-DI
00810075281262
Basic UDI-DI
081007528925UPSLLB9L
Direct Marketing DI
00810075281262
FDA Product Code
CCX
EMDN Code
V080302 Patient positioning medical cushions
GMDN Term
Operating table patient positioning set, reusable
Device Class
Class I
Regulation Number
868.6820
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Height — 6.75 Inch
Width — 23.5 Inch
Length — 39.5 Inch

Manufacturer details

EUDAMED SRN
US-MF-000035043
Authorised representative
Bone Foam B.V. NL-AR-000035735

Other devices from Bone Foam, Inc.

See all devices from Bone Foam, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

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