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Tissue saturation oximeter sensors

by Suzhou Engin Bio-medical Electronics Co., Ltd. 4 variants

Ref 06972772850159Model EA11、EA21、EB11、EB21、EB13

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697277285002NF Basic UDI-DI 06972772850159UDI-DIDate14 Sep 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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
EA11、EA21、EB11、EB21、EB13, 06972772850159
Primary DI / UDI-DI
06972772850159
Basic UDI-DI
697277285002NF
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017172
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from Suzhou Engin Bio-medical Electronics Co., Ltd.

See all devices from Suzhou Engin Bio-medical Electronics Co., Ltd. →

Properties

  • Measuring Function

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No