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Oci

by Chengdu Oci Medical Devices Co., Ltd. China EUDAMED

Ref OCI-BL-PVCModel OCI-BL-HDA,-HDB,-HSA,-HSB,-HSC:(c1-d1),(b1-c1-d1),(b2-c1-d1),(a1-b1-c1-d1),(a1-b2-c1-d1); OCI-BL-PLA,-PLB,-PLC; OCI-BL-PFB,-PFC,-PFG;-PFN,-PFS,-PFT; OCI-BL-PAA,-PAB,-PAD,-PAE,-PAF; OCI-BL-PVA,-PVB,-PVC,-PVD,-PVE.

EMDN F020199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69379093HBTS004YH Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Sterile Hemodialysis Blood Tubing Sets
Model / Reference
OCI-BL-HDA, -HDB, -HSA, -HSB, -HSC:(c1-d1), (b1-c1-d1), (b2-c1-d1), (a1-b1-c1-d1), (a1-b2-c1-d1), OCI-BL-PLA, -PLB, -PLC, OCI-BL-PFB, -PFC, -PFG, -PFN, -PFS, -PFT, OCI-BL-PAA, -PAB, -PAD, -PAE, -PAF, OCI-BL-PVA, -PVB, -PVC, -PVD, -PVE., OCI-BL-PVC
Primary DI / UDI-DI
06937909327492, 06937909308248
Basic UDI-DI
69379093HBTS004YH, 69379093HBTS003YF
EMDN Code
F020199 Arteriovenous dialysis lines for haemodialysis - haemofiltration -haemodiafiltration - other
Device Class
Class IIa
Market of Registration
Greece

Manufacturer details

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

Other devices from Chengdu Oci Medical Devices Co., Ltd.

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    Class IIb

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • CMR Substance
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 26728932-6b4e-4655-a110-a7459deb2175 61 fields · synced 24 Oct 2026
  • EUDAMED 06937909308248|69379093HBTS003YF 61 fields · synced 19 May 2026