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TrakCare Middle East

by InterSystems Corporation

Ref TCMEXX

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0850013533SYSXXZL Basic UDI-DI 00850013533114UDI-DIDate26 May 2026RegisteredStatusActive EUDAMED: not on the EU market

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
IntelliCare
Model / Reference
TCMEXX
Primary DI / UDI-DI
00850013533114
Basic UDI-DI
0850013533SYSXXZL
Direct Marketing DI
00850013533114
EMDN Code
Z12040192, Z12040292
Device Class
Class IIa
Special Device Type
Software

Manufacturer details

EUDAMED SRN
US-MF-000048003
Authorised representative
MDSS GmbH DE-AR-000005430

From the manufacturer

Manufacturer's product page: Middle East

Other devices from InterSystems Corporation

See all devices from InterSystems Corporation →

Properties

Other properties (13)

  • Sterile: 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