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Fingertip Pulse Oximeter

by Shenzhen Witleaf Medical Electronics Co., Ltd 4 variants

Ref WIT-S400

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K213430↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-06970005391011 Basic UDI-DI 06970005391011UDI-DIDate31 Oct 2024RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06970005391011 Basic UDI-DI 06970005391011UDI-DIDate31 Oct 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK213430 Date30 Dec 2022IssuedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR, CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
WIT-S400
Primary DI / UDI-DI
06970005391011
Basic UDI-DI
B-06970005391011, 697000539FPO31BL
Direct Marketing DI
06970005391011
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIa
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