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Pulse Oximeter

by Shenzhen Envisen Industry Co., Ltd. 2 variants

Ref HandyOxi500

Pulse Oximeter (HandyOxi500) is a Class IIb device made by Shenzhen Envisen Industry Co., Ltd., registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-06971449611994), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971449611994 Basic UDI-DI Date22 Sep 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
HandyOxi500
Primary DI / UDI-DI
06971449611994, 06971449611239, 06971449611987
Basic UDI-DI
B-06971449611994, B-06971449611239, B-06971449611987
EMDN code
Z1203020408 Pulse oximeters
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010838
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Similar devices in this category

Other devices filed under PULSE OXIMETERS.

Other devices from Shenzhen Envisen Industry Co., Ltd.

See all devices from Shenzhen Envisen Industry Co., Ltd. →

Properties

  • Reusable
  • Measuring function
Other properties (12, all answered No)