Identity
- Trade Name
- ASAHI VIE EUDAMED
- Device Name
- ASAHI ViE-X SERIES DIALYZER EUDAMED
- Model / Reference
- ViE-18X EUDAMEDSVIE18X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693006515 EUDAMED
- Basic UDI-DI
- B-04537693006515 EUDAMED
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Asahi Vie by Asahi Kasei Medical Co., Ltd. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04537693006515 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04537693006515 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Asahi Kasei Medical Co., Ltd.
- EUDAMED SRN
- JP-MF-000013951
- Authorised Representative
- Asahi Kasei Medical Europe GmbH DE-AR-000012752
Sources (1)
- EUDAMED 96b3f463-7860-4b6f-a056-229ca3d8d287 61 fields · synced Oct 7, 2026