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SpO2 Sensor

by Shanghai Berry Electronic Tech Co., Ltd. 3 variants

Ref BSA09001B

SpO2 Sensor (BSA09001B) is a Class IIa device made by Shanghai Berry Electronic Tech Co., Ltd., registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI B-06924054329020), active as of 7 Nov 2026.

Active European Union

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06924054329020 Basic UDI-DI 06924054329020UDI-DIDate26 Oct 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
BSA09001B
Primary DI / UDI-DI
06924054329020
Basic UDI-DI
B-06924054329020
EMDN code
C900301 Pulse oximeter sensors
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000035103
Authorised representative
Prolinx GmbH DE-AR-000005129

Similar devices in this category

Other devices filed under PULSE OXIMETER SENSORS.

Other devices from Shanghai Berry Electronic Tech Co., Ltd.

See all devices from Shanghai Berry Electronic Tech Co., Ltd. →

Properties

  • Reprocessed single-use device
  • Measuring function
Other properties (10, all answered No)