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Rexeed
EUDAMEDClass IIb (EU MDR)
Ref SREXEED25AModel REXEED-25ARef 60SREXEED25AM
Identity
- Trade Name
- REXEED EUDAMED
- Device Name
- ASAHI REXEED-A SERIES DIALYZER EUDAMED
- Model / Reference
- REXEED-25A EUDAMEDSREXEED25A EUDAMED60SREXEED25AM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693003880 EUDAMED
- Basic UDI-DI
- B-04537693003880 EUDAMED4537693REX-A/0017C 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 — 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-04537693003880 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04537693003880 | 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 22f360d1-771d-4bd1-9bc1-c45c59a86c4e 61 fields · synced Jun 9, 2026
- EUDAMED 6c4ad7d4-d26e-403b-82f6-ca97e9af6ee8 61 fields · synced May 17, 2026