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OCI-BD-S-B(b1)
EUDAMEDClass IIa (EU MDR)
Ref OCI-BD-S-B(b1)Model Hemodialysis Blood Tubing SetsRef OCI-BD-S-B
Identity
- Trade Name
- OCI-BD-S-B(b1) EUDAMEDOCI-BD-S-B EUDAMED
- Device Name
- Hemodialysis Blood Tubing Sets EUDAMED
- Model / Reference
- Hemodialysis Blood Tubing Sets EUDAMEDOCI-BD-S-B(b1) EUDAMEDOCI-BD-S-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909303335 EUDAMED06937909326099 EUDAMED06937909303311 EUDAMED06937909326112 EUDAMED
- Basic UDI-DI
- 69379093HBTS001YB EUDAMED69379093HBTS002YD EUDAMEDB-06937909303311 EUDAMED
- EMDN Code
- F020199 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMEDGreece 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-BD-S-B(b1) by Chengdu Oci Medical Devices Co., Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69379093HBTS001YB | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69379093HBTS001YB | Class IIa | 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 (5)
- EUDAMED 530feaae-8798-40b1-a2e6-d5da056c3134 61 fields · synced Oct 6, 2026
- EUDAMED 9104e237-0d19-4c02-a098-84d2b2aef2f4 61 fields · synced May 18, 2026
- EUDAMED 989df62b-ef4d-407c-9a2f-81fceac7a720 61 fields · synced May 19, 2026
- EUDAMED 3264a52e-c251-45d3-990d-76273d3e98e1 61 fields · synced May 19, 2026
- EUDAMED e89c3668-6064-4025-a853-5d3f21268575 61 fields · synced Jul 22, 2026