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DORA Tubing Sets for Hemodialysis

by Bain Medical Equipment(Guangzhou)Co., Ltd. China EUDAMED

Ref BAIN-BL-252Model BAIN-BL-001, BAIN-BL-029, BAIN-BL-034, BAIN-BL-088, BAIN-BL-130, BAIN-BL-132, BAIN-BL-141, BAIN-BL-173, BAIN-BL-252 EMDN F020102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number6948082701181A6 Basic UDI-DIDate10 Mar 2026RegisteredStatusActive
European UnionCE/MDR Number6948082701181A6 Basic UDI-DIDate10 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Trade Name
DORA Tubing Sets for Hemodialysis
Dora
Device Name
Tubing Sets for Hemodialysis
Model / Reference
BAIN-BL-001, BAIN-BL-029, BAIN-BL-034, BAIN-BL-088, BAIN-BL-130, BAIN-BL-132, BAIN-BL-141, BAIN-BL-173, BAIN-BL-252
Primary DI / UDI-DI
06948082707155
Basic UDI-DI
6948082701181A6, B-06948082707155
EMDN Code
F020102 Arteriovenous dialysis lines, two needles
Device Class
Class IIa
Market of Registration
Bulgaria

Manufacturer details

EUDAMED SRN
CN-MF-000005196
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Bain Medical Equipment(Guangzhou)Co., Ltd.

See all devices from Bain Medical Equipment(Guangzhou)Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance YesEUDAMEDNoEUDAMED
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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 9053fad0-0c55-48d6-8a38-131fee16dbc2 61 fields · synced 23 Oct 2026
  • EUDAMED 06948082707155|B-06948082707155 61 fields · synced 11 Oct 2026