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Pica

by Time Medical Limited

Ref TMS-MRI-3500WB

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-TMSMRI3500WBH6 Basic UDI-DI D-TMSMRI3500WBH6UDI-DIDate13 Aug 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
PICA Wholebody MRI System
Model / Reference
TMS-MRI-3500WB
Primary DI / UDI-DI
D-TMSMRI3500WBH6
Basic UDI-DI
B-TMSMRI3500WBH6
EMDN Code
Z11050102 Open magnet MRI scanners with magnetic field intensity less than or equal to 0.5t
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
HK-MF-000019852
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Time Medical Limited

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No