Certificate valid

Snapshot 2026-10-09 · Link to EUDAMED

OCI

UDI-DI 06937909305131Basic UDI-DI 69379093PHFH003XW

Class IIb · MDR · CHENGDU OCI MEDICAL DEVICES CO., LTD.

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Identification

Model: OCI-HD13M, OCI-HD15M, OCI-HD16M, OCI-HD17M, OCI-HD18M, OCI-HD19M, OCI-HD20M, OCI-HD21M, OCI-HD22M, OCI-HD23M, OCI-HD24M, OCI-HD25M, OCI-HF160, OCI-HF170, OCI-HF180, OCI-HF200, OCI-HF210, OCI-HF220, OCI-HF230, OCI-HF240, OCI-HF250
EMDN: F01060303
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

CN26/00004173

EU quality management system · valid

Notified body: SGS Belgium NV (1639)

Valid from 2026-06-05 · Expiry 2031-06-05

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

CHENGDU OCI MEDICAL DEVICES CO., LTD.

SRN CN-MF-000009700

CN · Chengdu, Sichuan Province

manufacturer

Authorised representative: Lepu Medical (Europe) Cooperatief U.A. (NL-AR-000000551)

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Showing 12 of 20 other UDI-DIs.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/oci-5131 · UDI page: /udi/06937909305131

All devices from CHENGDU OCI MEDICAL DEVICES CO., LTD.

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