Identity
- Trade Name
- APS EUDAMED
- Device Name
- ASAHI APS-HE SERIES HEMODIAFILTER EUDAMED
- Model / Reference
- APS18HE EUDAMEDAPS26HE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693006836 EUDAMED04537693006850 EUDAMED
- Basic UDI-DI
- 4537693APSHE/001AX 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
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
Aps by Asahi Kasei Medical Co., Ltd. — Class IIb — 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 | 4537693APSHE/001AX | 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 (2)
- EUDAMED 280ec42e-b5ad-42c8-95d7-a495f2301cc6 61 fields · synced Oct 6, 2026
- EUDAMED 50e1e4a7-9968-41c4-8116-7ca667e0a8b3 61 fields · synced Jul 23, 2026