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OCI-BL-HDB(a1-b1-c1-d1)
EUDAMEDClass IIa (EU MDR)
Ref OCI-BL-HDB(a1-b1-c1-d1)Model Hemodialysis Blood Tubing Sets
Identity
- Trade Name
- OCI-BL-HDB(a1-b1-c1-d1) EUDAMED
- Device Name
- Hemodialysis Blood Tubing Sets EUDAMED
- Model / Reference
- Hemodialysis Blood Tubing Sets EUDAMEDOCI-BL-HDB(a1-b1-c1-d1) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909368013 EUDAMED06937909327102 EUDAMED
- Basic UDI-DI
- 69379093HBTS003YF EUDAMED69379093HBTS004YH EUDAMED
- EMDN Code
- F020199 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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-BL-HDB(a1-b1-c1-d1) 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 | 69379093HBTS003YF | 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 (2)
- EUDAMED 50b6619d-374d-44c5-8318-455850e84ae4 61 fields · synced Oct 6, 2026
- EUDAMED 0c26eaa2-ab12-4bd3-93d7-24731e9a2b43 61 fields · synced May 19, 2026