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IPPS™ Overlay MTIL6520

by Medtec LLC EUDAMEDGUDID

Active European Union

Ref MTIL6520

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8414391OC0007R01B6 Basic UDI-DIDate22 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439106143 UDI-DIDate2 Aug 2017ListedStatusListed 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  • Withdrawn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

7 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-3021-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010
    • Terminated Z-3020-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010
    • Terminated Z-3019-2011 FDA Unclassified (pre-2012) initiated 30 Dec 2010

    Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.

  • 3 recalls, same reason

    • Terminated Z-0396-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010
    • Terminated Z-0395-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010
    • Terminated Z-0394-2011 FDA Unclassified (pre-2012) initiated 21 Jun 2010

    Under certain conditions, the extensions can become detached from the main body of the couch.

    • Terminated Z-1721-2009 FDA Unclassified (pre-2012) initiated 6 Mar 2009

    The silkscreened indexing scale was reversed.

Specification

EUDAMED · GUDID

Trade Name
IPPS™ Overlay
Generic Name
Indexed-immobilization patient positioning system
Device Name
Couchtop
Model / Ref / Catalog
MTIL6520
Primary DI / UDI-DI
00841439106143
Basic UDI-DI
8414391OC0007R01B6
510(k) Number
FDA Product Code
IXQ
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
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K973842)

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