Identity
- Trade Name
- REXEED EUDAMED
- Device Name
- ASAHI REXEED-AE SERIES DIALYZER EUDAMED
- Model / Reference
- REXEED-15AE EUDAMED60SREXEED18AE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693007420 EUDAMED
- Basic UDI-DI
- 4537693REXAE/001GF 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
Rexeed by Asahi Kasei Medical Co., Ltd. — Class IIb — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4537693REXAE/001GF | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K153344 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4537693REXAE/001GF | 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 1a3f45f8-bbbc-4a5a-b157-740b6e0f98a7 61 fields · synced Oct 7, 2026
- FDA 510(k) K153344 1 fields · synced May 18, 2026