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OCI-BD-D-B(a1-b1)
EUDAMEDClass IIa (EU MDR)
Ref OCI-BD-D-B(a1-b1)Model Hemodialysis Blood Tubing SetsRef OCI-BD-D-B(a1-b2)Model OCI-BD-D-A, (b1), (a1), (a1-b1); OCI-BD-S-A, (b1), (a1), (a1-b1); OCI-BD-S-B, (b1), (a1), (a1-b1); OCI-BD-D-B, (b1), (b2), (a1-b1), (a1-b2); OCI-BD-D-C, (b1), (b2), (a1-b1), (a1-b2)
Identity
- Trade Name
- OCI-BD-D-B(a1-b1) EUDAMEDOCI EUDAMED
- Device Name
- Hemodialysis Blood Tubing Sets EUDAMEDSterile Hemodialysis Blood Tubing Sets EUDAMED
- Model / Reference
- Hemodialysis Blood Tubing Sets EUDAMEDOCI-BD-D-B(a1-b1) EUDAMEDOCI-BD-D-A, (b1), (a1), (a1-b1); OCI-BD-S-A, (b1), (a1), (a1-b1); OCI-BD-S-B, (b1), (a1), (a1-b1); OCI-BD-D-B, (b1), (b2), (a1-b1), (a1-b2); OCI-BD-D-C, (b1), (b2), (a1-b1), (a1-b2) EUDAMEDOCI-BD-D-B(a1-b2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909326174 EUDAMED06937909303458 EUDAMED
- Basic UDI-DI
- 69379093HBTS002YD EUDAMED69379093HBTS001YB 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-D-B(a1-b1) by Chengdu Oci Medical Devices Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69379093HBTS002YD | 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 (3)
- EUDAMED 83594f07-707e-4e81-9282-b83026eb2b59 61 fields · synced Oct 7, 2026
- EUDAMED 6be6c8c7-47cb-4ab7-96ef-8980d2ce134e 61 fields · synced May 17, 2026
- EUDAMED 50f1c2b8-a482-4f8a-aeef-29838af7af86 61 fields · synced Oct 7, 2026