Identity
- Device Name
- PlasautoΣ EUDAMED
- Model / Reference
- No.2023.6-G-0771 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04582270690359 EUDAMED
- Basic UDI-DI
- B-04582270690359 EUDAMED
- EMDN Code
- B030104 APHERESIS MULTIPLE BLOOD COMPONENT COLLECTION DEVICES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PlasautoΣ by Med-Tech 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-04582270690359 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Med-Tech Inc.
- EUDAMED SRN
- JP-MF-000016597
- Authorised Representative
- Asahi Kasei Medical Europe GmbH DE-AR-000012752
Sources (1)
- EUDAMED 306f1030-118e-4ff0-811b-16a63b91e3ab 61 fields · synced Jul 20, 2026