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Plasma Fractionator- Evaflux Evaflux 3A20
EUDAMEDClass IIb (EU MDR)
Ref Evaflux 3A20Model Plasma Fractionator- Evaflux Evaflux 3A20
Identity
- Device Name
- Plasma Fractionator- Evaflux Evaflux 3A20 EUDAMED
- Model / Reference
- Plasma Fractionator- Evaflux Evaflux 3A20 EUDAMEDEvaflux 3A20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488060169 EUDAMED
- Basic UDI-DI
- B-04987488060169 EUDAMED
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS 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
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 Fractionator- Evaflux Evaflux 3A20 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-04987488060169 | 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 61b11c52-984f-45f8-8f6c-bb0be3144a02 61 fields · synced Jul 9, 2026