Identity
- Trade Name
- PLASORBA EUDAMED
- Device Name
- PLASORBA BR-350(L) EUDAMED
- Model / Reference
- 60SBR350L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693001992 EUDAMED
- Basic UDI-DI
- 4537693PL-BR/001ZM EUDAMED
- EMDN Code
- B030203 SINGLE PLASMA COMPONENTS REMOVAL 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
CMR Substance
Yes
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
Plasorba by Asahi Kasei Medical Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4537693PL-BR/001ZM | 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 (1)
- EUDAMED 4bc6530d-6038-4aec-92cd-0739f53639ec 61 fields · synced Oct 7, 2026