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Oci-Bl-Pva
EUDAMEDClass IIa (EU MDR)
Ref OCI-BL-PVAModel Hemodialysis Blood Tubing Sets
Identity
- Trade Name
- OCI-BL-PVA EUDAMED
- Device Name
- Hemodialysis Blood Tubing Sets EUDAMED
- Model / Reference
- Hemodialysis Blood Tubing Sets EUDAMEDOCI-BL-PVA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909327478 EUDAMED
- Basic UDI-DI
- 69379093HBTS004YH 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-Pva 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 | 69379093HBTS004YH | 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 (1)
- EUDAMED 18eff7b8-bd53-4fbe-bd55-07721ae9635a 61 fields · synced Oct 6, 2026