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Oci

by Chengdu Oci Medical Devices Co., Ltd. 88 variants

Ref OCI-BD-D-AModel OCI-BD-D-A, (b1), (a1), (a1-b1); OCI-BD-S-A, (b1), (a1), (a1-b1); OCI-BD-S-B, (b1), (a1), (a1-b1); OCI-BD-D-B, (b1), (b2), (a1-b1), (a1-b2); OCI-BD-D-C, (b1), (b2), (a1-b1), (a1-b2)

Active European Union

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number69379093HBTS001YB Basic UDI-DI Date10 Aug 2026RegisteredStatusActive
European UnionCE/MDR Number69379093HBTS001YB Basic UDI-DI Date10 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD, CE/MDR Active

Specification

EUDAMED

Device Name
Sterile Hemodialysis Blood Tubing Sets
Model / Reference
OCI-BD-D-A, (b1), (a1), (a1-b1), OCI-BD-S-A, OCI-BD-S-B, OCI-BD-D-B, (b2), (a1-b2), OCI-BD-D-C
Primary DI / UDI-DI
06937909303113, 06937909326013
Basic UDI-DI
69379093HBTS001YB, 69379093HBTS002YD, B-06937909303113
EMDN Code
F020199 Arteriovenous dialysis lines for haemodialysis - haemofiltration -haemodiafiltration - other
Device Class
Class IIa
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000009700
Authorised representative
Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551

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See all devices from Chengdu Oci Medical Devices Co., Ltd. →

Properties

  • 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