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Respiree 1BioAI-Acute

by Respiree Pte Ltd

Ref RS001.1BioAI-Acute

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G267RS001BIOAIACUTEE9 Basic UDI-DI ++G267RS0011BIOAIV1000/$RS0011BIOAIV100/16D20250509FUDI-DIDate29 May 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
RS001.1BioAI-Acute
Primary DI / UDI-DI
++G267RS0011BIOAIV1000/$RS0011BIOAIV100/16D20250509F
Basic UDI-DI
++G267RS001BIOAIACUTEE9
EMDN Code
Z1203020292 Multi-parameter monitors - medical device software
Device Class
Class IIa
Special Device Type
Software

Manufacturer details

EUDAMED SRN
SG-MF-000033374
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Respiree Pte, 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