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Patient Monitor

by Shenzhen Witleaf Medical Electronics Co., Ltd 80 variants

Ref EK12J

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 Number697000539PMWTEL63S21ES Basic UDI-DI 06970005396863UDI-DIDate12 May 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  • Withdrawn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/MDR Active

Specification

EUDAMED

Model / Reference
EK12J
Primary DI / UDI-DI
06970005396863
Basic UDI-DI
697000539PMWTEL63S21ES
Direct Marketing DI
06970005396863
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
Device Class
Class IIb
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000040494
Authorised representative
Zug Medical Systems FR-AR-000032031

Other devices from Shenzhen Witleaf Medical Electronics Co., Ltd.

See all devices from Shenzhen Witleaf Medical Electronics Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • 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
  • Incorporates Medicinal Product: No