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Mask DSPS®-PROSC set/5 113770

by Macromedics B.V. EUDAMEDGUDID

Active European Union

Ref 113770

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number872016816113000GT Basic UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08720168162861 UDI-DIDate22 Apr 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Mask DSPS®-PROSC set/5
Generic Name
Patient positioning thermoplastic mould material
Device Name
DSPS-Prominent
Model / Reference
113770
Primary DI / UDI-DI
08720168162861
Basic UDI-DI
872016816113000GT
510(k) Number
FDA Product Code
IYE, LNH
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, 892.1000
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K250429)

Other devices from Macromedics B.V.

See all devices from Macromedics B.V. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Premarket Exempt: No
  • Serial Number: No