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Fitting/Adapters

by Orantech Inc. 21 variants

Ref BPC01P-45

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, self-declared

Class I: no certifier involved

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 Number69416919ORANTECH20QT Basic UDI-DI 06941691981404UDI-DIDate13 Mar 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
BPC01P-45
Primary DI / UDI-DI
06941691981404
Basic UDI-DI
69416919ORANTECH20QT
EMDN Code
Z1203020285 Multi-parameter monitors - consumables
Device Class
Class I
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000013859
Authorised representative
Medten EU ApS DK-AR-000034434

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from Orantech Inc.

See all devices from Orantech Inc. →

Properties

Other properties (13)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No