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SpO2 sensor

by Shenzhen Ykd Technology Co., Ltd. 10 variants

Ref CSL066C-B, CSL024D, CSL024B, CSS032D, CSL045B, CSS032B, CSL024F, CSS032C-B, CSL045D, CSL045C-B, CSL066F

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251751↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k) 510(k) NumberK251751 Date19 Dec 2025IssuedStatusActive
European UnionCE/MDD EUDAMED NumberB-06975319831772 Basic UDI-DI Date26 Dec 2024RegisteredStatusActive

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 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
CSL066C-B, CSL024D, CSL024B, CSS032D, CSL045B, CSS032B, CSL024F, CSS032C-B, CSL045D, CSL045C-B, CSL066F
Primary DI / UDI-DI
06975319831772, 06975319831680, 06975319831673, 06975319831635, 06975319831710, 06975319831628, 06975319831703, 06975319831642, 06975319831727, 06975319831734, 06975319831789
Basic UDI-DI
B-06975319831772, B-06975319831680, B-06975319831673, B-06975319831635, B-06975319831710, B-06975319831628, B-06975319831703, B-06975319831642, B-06975319831727, B-06975319831734, B-06975319831789
EMDN Code
C900301 Pulse oximeter sensors
Device Class
Class IIb
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017263
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Related devices

Category: Pulse oximeter probe, single-use

Other devices from Shenzhen Ykd Technology Co., Ltd.

See all devices from Shenzhen Ykd Technology Co., Ltd. →

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