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Oci

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

Ref OCI-17G(25), OCI-17G(32), OCI-17GModel OCI-14G(25);OCI-14G(32);OCI-15G(25);OCI-15G(32);OCI-16G(25);OCI-16G(32);OCI-17G(25);OCI-17G(32)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69379093AFNS001U6 Basic UDI-DI Date7 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  • Withdrawn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 Arteriovenous Fistula Needle Sets
Model / Reference
OCI-14G(25), OCI-14G(32), OCI-15G(25), OCI-15G(32), OCI-16G(25), OCI-16G(32), OCI-17G(25), OCI-17G(32), OCI-17G
Primary DI / UDI-DI
06937909306176, 06937909306718
Basic UDI-DI
69379093AFNS001U6, B-06937909306718, B-06937909306176
EMDN Code
A010401 Arteriovenous fistula needles
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
  • 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