Skip to content

iFIX Head Mask XL

by iSYS Medizintechnik GmbH

Ref 29341

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, self-declared

Class I: no certifier involved

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 Number9010279iFIX6V Basic UDI-DI 09010279000176UDI-DIDate7 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number09010279000176 UDI-DI Date31 Mar 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
iFIX Head Mask XL EUDAMED
iFIX GUDID
Generic Name
Limb/torso/head restraint, single-use
Device Name
iFIX Product Line
Model / Ref / Catalog
29341, Head Mask XL
Primary DI / UDI-DI
09010279000176 EUDAMED
29010279000170 GUDID
Basic UDI-DI
9010279iFIX6V
FDA Product Code
FMQ
EMDN Code
V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures)
GMDN Term
Limb/torso/head restraint, single-use
Device Class
Class I
Regulation Number
880.6760
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe
Size
Length — 325 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
29341
GUDID
Head Mask XL
Primary DI / UDI-DIEUDAMED
09010279000176
GUDID
29010279000170

Manufacturer details

EUDAMED SRN
AT-MF-000000275

Other devices from iSYS Medizintechnik GmbH

See all devices from iSYS Medizintechnik GmbH →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

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