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SpO2 sensor

by Edan Instruments, Inc. 2 variants

Part of a family of 12 devices: see the family page

Ref SH31D701

SpO2 sensor (SH31D701) is a Class IIb device made by Edan Instruments, Inc., registered in EUDAMED on 29 Jan 2026 (Basic UDI-DI 69444138SSG8), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

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

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69444138SSG8 Basic UDI-DI 06944413837973UDI-DIDate29 Jan 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
SH31D701
Primary DI / UDI-DI
06944413837973
Basic UDI-DI
69444138SSG8
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
Device class
Class IIb
EU registration type
Standard device
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES.

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Measuring function
Other properties (13, all answered No)