Identity
- Trade Name
- Plasmaflo EUDAMEDPLASMAFLO AP-05H ASAHI PLASMA SEPARATOR FDA PMA
- Generic Name
- Separator for therapeutic purposes, membrane automated blood cell/plasma FDA PMA
- Device Name
- Plasmaflo OP EUDAMED
- Model / Reference
- OP-08W(L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04537693001893 EUDAMED
- Basic UDI-DI
- 4537693PL-OP/0016B EUDAMED
- PMA Number
- P820033 FDA PMA
- FDA Product Code
- MDP FDA PMA
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA PMA
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 FDA PMA
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Plasmaflo OP-05W is a membrane-based automated separator designed for therapeutic purposes. It functions by facilitating the separation of blood cells and plasma during clinical procedures.
This device is manufactured by Asahi Kasei Medical Co., Ltd. and is subject to FDA PMA and MDR regulatory authorizations. It is categorized as a membrane automated blood cell and plasma separator for therapeutic use.
Frequently asked questions
What is the primary function of the Plasmaflo OP-05W?
The Plasmaflo OP-05W is a membrane-based device designed to automate the separation of blood cells and plasma for therapeutic applications.
Who is the manufacturer of this plasma separator?
The device is manufactured by Asahi Kasei Medical Co., Ltd., based in Tokyo, Japan.
Is the Plasmaflo OP-05W authorized for use?
Yes, the device has received FDA PMA approval and complies with MDR requirements for its classification as a therapeutic membrane separator.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Plasmaflo OP specifications - Asahi Kasei Medical, ASAHI KASEI MEDICAL CO., LTD. PLASMAFLO OP, Premarket Approval (PMA) - FDA, Plasmaflo OP-05W(A) PMA P820033 - FDA.report, PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR (P820033 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P820033 | Class III | Active |
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Manufacturer
- Manufacturer
- Asahi Kasei Medical Co., Ltd.
Sources (2)
- FDA PMA P820033 24 fields · synced Oct 6, 2026
- EUDAMED 89a94f88-564f-42ab-be3a-9dcdd67bb1f9 61 fields · synced Jul 17, 2026