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Rexeed
EUDAMEDClass IIb (EU MDR)
Ref 60SREXEED21LMRef SREXEED21LModel REXEED-21L
Identity
- Trade Name
- REXEED EUDAMED
- Device Name
- ASAHI REXEED-L SERIES DIALYZER EUDAMED
- Model / Reference
- 60SREXEED21LM EUDAMEDREXEED-21L EUDAMEDSREXEED21L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693004146 EUDAMED
- Basic UDI-DI
- 4537693REX-L/001B5 EUDAMEDB-04537693004146 EUDAMED
- EMDN Code
- F01060203 DIALYSERS - UFC = 18 - 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, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4537693REX-L/001B5 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 4537693REX-L/001B5 | 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 ffd927ec-b3fd-42e8-8a3e-28e6e380f87c 61 fields · synced Oct 6, 2026
- EUDAMED d61748c8-9d01-4169-9a38-3e5389bcf416 61 fields · synced May 18, 2026