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ProForm™ Pediatric MR Overlay PRO420

by Medtec LLC EUDAMEDGUDID

Active European Union

Ref PRO420

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0007R01B6 Basic UDI-DIDate22 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439113950 UDI-DIDate20 Aug 2022ListedStatusListed 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  • Withdrawn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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
ProForm™ Pediatric MR Overlay
Generic Name
Indexed-immobilization patient positioning system
Device Name
Couchtop
Model / Ref / Catalog
PRO420
Primary DI / UDI-DI
00841439113950
Basic UDI-DI
8414391OC0007R01B6
510(k) Number
FDA Product Code
IXQ, IYE
EMDN Code
Z12011299 Patient positioning instruments – other
GMDN Term
Indexed-immobilization patient positioning system
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1980, 892.5050
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 (K180021)

Show all (12)

Other devices from Medtec LLC

See all devices from Medtec LLC →

Properties

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