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Handheld Pulse Oximeter

by Shenzhen Creative Industry Co., Ltd. 3 variants

Ref SP-20Model SP-20、PC-66A

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 Number69419006HPOximeter0102HN Basic UDI-DI 06941900606760UDI-DIDate25 Mar 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  • Withdrawn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
SP-20、PC-66A, SP-20
Primary DI / UDI-DI
06941900606760
Basic UDI-DI
69419006HPOximeter0102HN
Direct Marketing DI
06941900606760
EMDN Code
Z1203020408 Pulse oximeters
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000009430
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

From the manufacturer

Manufacturer's product page: Pulse Oximeters

Other devices from Shenzhen Creative Industry Co., Ltd.

See all devices from Shenzhen Creative Industry 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