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Rexeed
EUDAMEDClass IIb (EU MDR)
Ref SREXEED15LModel REXEED-15LRef 60SREXEED15LM
Identity
- Trade Name
- REXEED EUDAMED
- Device Name
- ASAHI REXEED-L SERIES DIALYZER EUDAMED
- Model / Reference
- REXEED-15L EUDAMEDSREXEED15L EUDAMED60SREXEED15LM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693004122 EUDAMED
- Basic UDI-DI
- B-04537693004122 EUDAMED4537693REX-L/001B5 EUDAMED
- EMDN Code
- F01060103 DIALYSERS - UFC < 18 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-04537693004122 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-04537693004122 | 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 (3)
- EUDAMED 96410894-7a8b-4acf-99bf-281db6632dba 61 fields · synced Oct 7, 2026
- EUDAMED af117934-3d71-4863-8655-64189bbc90c5 61 fields · synced May 18, 2026
- EUDAMED afbb4483-39a8-4f0a-aad8-63b8dba1fb36 61 fields · synced Oct 7, 2026