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OCI-BD-D-C(b2)
EUDAMEDClass IIa (EU MDR)
Ref OCI-BD-D-C(b2)Model Hemodialysis Blood Tubing SetsRef OCI-BD-D-C
Identity
- Trade Name
- OCI-BD-D-C(b2) EUDAMEDOCI-BD-D-C EUDAMED
- Device Name
- Hemodialysis Blood Tubing Sets EUDAMED
- Model / Reference
- Hemodialysis Blood Tubing Sets EUDAMEDOCI-BD-D-C(b2) EUDAMEDOCI-BD-D-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06937909326198 EUDAMED06937909326181 EUDAMED06937909303519 EUDAMED06937909303526 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 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-C(b2) 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 (4)
- EUDAMED 3f5fb6a9-9e95-476e-8393-a4900f89eeb3 61 fields · synced Oct 5, 2026
- EUDAMED a32ea285-67b9-4e05-8b09-31531886a57a 61 fields · synced May 17, 2026
- EUDAMED 009bcc81-6815-453b-ad19-e82bc564c671 61 fields · synced May 18, 2026
- EUDAMED 6090149a-32a3-478a-8758-0ee43a737641 61 fields · synced May 19, 2026