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Plasma Component Separator- Rheofilter ER ER-4000
EUDAMEDClass IIb (EU MDR)
Ref ER-4000Model Plasma Component Separator- Rheofilter ER ER-4000
Identity
- Device Name
- Plasma Component Separator- Rheofilter ER ER-4000 EUDAMED
- Model / Reference
- Plasma Component Separator- Rheofilter ER ER-4000 EUDAMEDER-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488060459 EUDAMED
- Basic UDI-DI
- B-04987488060459 EUDAMED
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Plasma Component Separator- Rheofilter ER ER-4000 by Sb-Kawasumi Laboratories, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04987488060459 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED a7901dfd-3cd7-45ae-90f2-ca8742889dc9 61 fields · synced Jul 22, 2026