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Mask DSPS®-PROSVR, set/5 DSPS-PROSVR

by Macromedics B.V.

Ref 113970

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
European UnionCE/MDR EUDAMED Number872016816113000GT Basic UDI-DI 08720168162236UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08720168162236 UDI-DI Date21 Apr 2023ListedStatusListed 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  • Withdrawn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
Mask DSPS®-PROSVR, set/5
Generic Name
Patient positioning thermoplastic mould material
Model / Ref / Catalog
113970, DSPS-PROSVR
Primary DI / UDI-DI
08720168162236
Basic UDI-DI
872016816113000GT
FDA Product Code
IYE
EMDN Code
Z12011285 Patient positioning instruments - consumables
GMDN Term
Patient positioning thermoplastic mould material
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
113970
GUDID
DSPS-PROSVR
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Macromedics B.V.

See all devices from Macromedics B.V. →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No