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Gateway

by Bistos Co., Ltd.

Ref BT-710

Gateway (BT-710) is a Class IIb device made by Bistos Co., Ltd., registered in EUDAMED on 26 Nov 2025 (Basic UDI-DI B-08800012371004), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800012371004 Basic UDI-DI 08800012371004UDI-DIDate26 Nov 2025RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device name
Pulse Oximeter
Model / reference
BT-710
Primary DI / UDI-DI
08800012371004
Basic UDI-DI
B-08800012371004
EMDN code
Z1203020408 Pulse oximeters
Device class
Class IIb
EU registration type
Legacy device (under a directive)
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000035951
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Bistos Co., Ltd.

See all devices from Bistos Co., Ltd. →

Properties

  • Measuring function
Other properties (11, all answered No)