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Blood Tubing Lines for Hemodialysis
EUDAMEDClass IIa (EU MDR)
Ref DO-F418-00Model AV18AFB-SNPModel AV18AFB-PModel AV18AFA-PModel AV18AFB-HFPModel AV18AFA-SNP
Identity
- Trade Name
- Blood Tubing Lines for Hemodialysis EUDAMED
- Device Name
- Blood Tubing Lines for Hemodialysis EUDAMED
- Model / Reference
- AV18AFB-SNP EUDAMEDDO-F418-00 EUDAMEDAV18AFB-P EUDAMEDAV18AFA-P EUDAMEDAV18AFB-HFP EUDAMEDAV18AFA-SNP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987671200013 EUDAMED04987671200044 EUDAMED04987671200020 EUDAMED04987671200051 EUDAMED04987671200006 EUDAMED
- Basic UDI-DI
- B-04987671200013 EUDAMEDB-04987671200044 EUDAMEDB-04987671200020 EUDAMEDB-04987671200051 EUDAMEDB-04987671200006 EUDAMED
- EMDN Code
- F020199 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Blood Tubing Lines for Hemodialysis by Nikkiso Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04987671200013 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nikkiso Co., Ltd.
- EUDAMED SRN
- JP-MF-000019276
- Authorised Representative
- NIKKISO Medical Europe GmbH DE-AR-000042794
Sources (5)
- EUDAMED 3e7d6786-b5d3-418f-a34a-b3de010f68ac 61 fields · synced Oct 6, 2026
- EUDAMED 00b3df74-ef14-49e6-ab33-d641d1f9f942 61 fields · synced May 16, 2026
- EUDAMED 89527b64-47b5-48eb-b50a-83986e6ff0d7 61 fields · synced May 17, 2026
- EUDAMED 57133f7f-1f05-40b4-b8da-9397fe5dd3e3 61 fields · synced Jul 21, 2026
- EUDAMED 081c854b-334a-4ad7-872a-f2de10869ff9 61 fields · synced Aug 2, 2026