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Bioteq

by Bioteque Corporation FDA registration: Taiwan EUDAMED

Ref BT-SC7-1054NWFD7 EMDN R050102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471988267CSCRN Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Closed Suction Catheter Set
Model / Reference
BT-SC7-1054NWFD7
Primary DI / UDI-DI
04719882684463
Basic UDI-DI
471988267CSCRN
EMDN Code
R050102 Closed-circuit respiratory suction and irrigation systems (non-endoscopic)
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
TW-MF-000015568
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Bioteque Corp.

See all devices from Bioteque Corp. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (1)

  • EUDAMED 04719882684463|471988267CSCRN 61 fields · synced 25 Oct 2026