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F380

by Shenzhen Fitfaith Technology Co., Ltd.

Ref 380Model F380

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697095326F380FP Basic UDI-DI 69709532601176UDI-DIDate24 Jan 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  • Withdrawn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

Device Name
Handheld Pulse Oximeter
Model / Reference
F380, 380
Primary DI / UDI-DI
69709532601176
Basic UDI-DI
697095326F380FP
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000019124
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shenzhen Fitfaith Technology Co., Ltd

Properties

  • Contains Latex
  • Measuring Function

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: 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