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Oci

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

Ref OCI-BL-PFTModel 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.

Active European Union

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69379093HBTS003YF Basic UDI-DI Date11 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  • Withdrawn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/MDR Active

Specification

EUDAMED

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-PFT
Primary DI / UDI-DI
06937909308484, 06937909327621
Basic UDI-DI
69379093HBTS003YF, 69379093HBTS004YH
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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Properties

  • 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