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DORA Tubing Sets for Hemodialysis

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

Active European Union

Ref BAIN-BL-109EModel BAIN-BL-002E,BAIN-BL-006E,BAIN-BL-009E,BAIN-BL-010E,BAIN-BL-014E,BAIN-BL-034E,BAIN-BL-036E,BAIN-BL-037E,BAIN-BL-038E,BAIN-BL-053E,BAIN-BL-059E,BAIN-BL-064E,BAIN-BL-069E,BAIN-BL-070E,BAIN-BL-075E,BAIN-BL-084E,BAIN-BL-108E,BAIN-BL-109E,BAIN-BL-110E

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6948082701182A8 Basic UDI-DIDate13 Mar 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  • Withdrawn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

Trade Name
DORA Tubing Sets for Hemodialysis
Dora
Device Name
Tubing Sets for Hemodialysis
Model / Reference
BAIN-BL-002E, BAIN-BL-006E, BAIN-BL-009E, BAIN-BL-010E, BAIN-BL-014E, BAIN-BL-034E, BAIN-BL-036E, BAIN-BL-037E, BAIN-BL-038E, BAIN-BL-053E, BAIN-BL-059E, BAIN-BL-064E, BAIN-BL-069E, BAIN-BL-070E, BAIN-BL-075E, BAIN-BL-084E, BAIN-BL-108E, BAIN-BL-109E, BAIN-BL-110E
Primary DI / UDI-DI
06948082773006
Basic UDI-DI
6948082701182A8, B-06948082773006
EMDN Code
F020102 Arteriovenous dialysis lines, two needles
Device Class
Class IIa
Market of Registration
Latvia

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

Show properties
  • 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