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IPPS™ Overlay MTIL6521

by Medtec LLC

Ref MTIL6521

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

7 closed

Documents

None linked in EUDAMED

A group certificate may exist

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 Number8414391OC0007R01B6 Basic UDI-DIDate22 Apr 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00841439106150 UDI-DIDate2 Aug 2017ListedStatusListed 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.

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.

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  • Withdrawn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
IPPS™ Overlay
Generic Name
Indexed-immobilization patient positioning system
Device Name
Couchtop
Model / Ref / Catalog
MTIL6521
Primary DI / UDI-DI
00841439106150
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