Identity
- Trade Name
- Plasmacure EUDAMED
- Device Name
- Plasmacure PE EUDAMED
- Model / Reference
- 60SPS02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693900677 EUDAMED
- Basic UDI-DI
- 4537693PL-PE/0012X 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
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
Plasmacure by Asahi Kasei Medical Co., Ltd. — Class IIb — CE/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-PE/0012X | 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 4b3c270c-9677-40f8-9a71-e6a48d4ed23e 61 fields · synced Oct 7, 2026