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Oci
EUDAMEDClass IIb (EU MDR)
Ref OCI-HD25MModel 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
Identity
- Trade Name
- OCI EUDAMED
- Device Name
- Polyethersulfone Hollow Fiber Hemodialyzer EUDAMEDSterile Polyethersulfone Hollow Fiber Hemodialyzer-H EUDAMED
- Model / Reference
- OCI-HD25M EUDAMEDOCI-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 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909305254 EUDAMED
- Basic UDI-DI
- B-06937909305254 EUDAMED69379093PHFH003XW EUDAMED
- Direct Marketing DI
- 06937909305254 EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Oci by Chengdu Oci Medical Devices Co., Ltd. — Class IIb — CE/MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06937909305254 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Chengdu Oci Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000009700
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (2)
- EUDAMED 481812a4-b622-4dd2-9f01-3505559d5d8a 61 fields · synced Oct 6, 2026
- EUDAMED 6cd4a6d5-69cb-475f-985c-945a02c8149f 61 fields · synced Sep 17, 2026