Oci
by Chengdu Oci Medical Devices Co., Ltd. China EUDAMED
Ref OCI-HF160Model 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
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69379093PHFH003XW | Date10 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CN26/00004173 Supplemented
Quality management system EU MDR
- Notified body
- Notified body 1639
- Issued
- 7 Jul 2026
- Expires
- 5 Jun 2031
- Reason
- Change approved
Specification
- Device Name
- Sterile Polyethersulfone Hollow Fiber Hemodialyzer-H
- Model / Reference
- 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
- Primary DI / UDI-DI
- 06937909302161
- Basic UDI-DI
- 69379093PHFH003XW
- Direct Marketing DI
- 06937909302161
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES
- Device Class
- Class IIb
- 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.
See all devices from Chengdu Oci Medical Devices Co., Ltd. →
Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 06937909302161|69379093PHFH003XW