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Tissue oxygen sensor

by Braincare (Beijing) medical device co. LTD 12 variants

Ref /Model BRS-1-CSL、BRS-1-CR、BRS-1-CL、BRS-1RE-CR、BRS-1RE-CXL、BRS-1RE-CSL、BRS-1RE-CL、BRS-1RE-C、BRS-1RE-CM、BRS-1RE-CSR、BRS-1-C、BRS-1-CSR、BRS-1-CM、BRS-1-CXL

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 Number697599094105SH Basic UDI-DI 06975990940527UDI-DIDate2 Jun 2026RegisteredStatusActive

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  • Withdrawn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
BRS-1-CSL、BRS-1-CR、BRS-1-CL、BRS-1RE-CR、BRS-1RE-CXL、BRS-1RE-CSL、BRS-1RE-CL、BRS-1RE-C、BRS-1RE-CM、BRS-1RE-CSR、BRS-1-C、BRS-1-CSR、BRS-1-CM、BRS-1-CXL, /
Primary DI / UDI-DI
06975990940527
Basic UDI-DI
697599094105SH
Direct Marketing DI
06975990940527
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
Device Class
Class IIb
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000026170
Authorised representative
NEO HEALTHIES LIMITED IE-AR-000000905

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Properties

  • Reusable

Other properties (12)

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