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Bioteq

by Bioteque Corporation United States EUDAMED

Ref BT-PD1-0825-W/ COD.VVVB00825/ D11008020, BT-PD1-0825-W

EMDN A060299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-04712052081284 Basic UDI-DIDate1 Jul 2026RegisteredStatusActive
European UnionCE/MDD NumberB-04712052081284 Basic UDI-DIDate1 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Drainage Catheter Set
Model / Reference
BT-PD1-0825-W/ COD.VVVB00825/ D11008020, BT-PD1-0825-W
Primary DI / UDI-DI
04712052081284
Basic UDI-DI
B-04712052081284, 471988271PDZG
EMDN Code
A060299 Percutaneous drainage systems - other
Device Class
Class IIa
Market of Registration
Denmark

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 (2)

  • EUDAMED a749ae4c-b5f2-44dd-be3f-97506a8fc6a7 61 fields · synced 25 Oct 2026
  • EUDAMED 04712052081284|471988271PDZG 61 fields · synced 25 Oct 2026