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Mölnlycke®Z-Flo™ Fluidized Positioner 1401005

by Mölnlycke Health Care AB

Ref 1401005

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number733243000000000000J8 Basic UDI-DI 07323190276455UDI-DIDate14 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07323190276455 UDI-DI Date21 Oct 2022ListedStatusListed 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  • Withdrawn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
Mölnlycke Z-Flo Fluidized Positioner, Adult EUDAMED
Mölnlycke®Z-Flo™ Fluidized Positioner GUDID
Generic Name
Freestanding patient positioner, single-use
Device Name
Mölnlycke Z-Flo Fluidized Positioner
Model / Reference
1401005
Primary DI / UDI-DI
07323190276455
Basic UDI-DI
733243000000000000J8
FDA Product Code
FMP
EMDN Code
V080302 Patient positioning medical cushions
GMDN Term
Freestanding patient positioner, single-use
Device Class
Class I
Regulation Number
880.6450
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Related devices

Category: Freestanding patient positioner, single-use

Other devices from Mölnlycke Health Care AB

See all devices from Mölnlycke Health Care AB →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • 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
  • Manufacturing Date: No