Identity
- Trade Name
- PLASMA ACTIVE EUDAMED
- Device Name
- Plasma Activator EUDAMED
- Model / Reference
- ACTILINK EUDAMEDMD2-0115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800066500559 EUDAMED
- Basic UDI-DI
- 88000665PLAATMEU2B EUDAMED
- Direct Marketing DI
- 08800066500559 EUDAMED
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta EUDAMED
Clinical & Handling
Sterile
No
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
Plasma Active by Plasmapp Co., Ltd. — Class I — 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 | 88000665PLAATMEU2B | Class I | Active |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd
- EUDAMED SRN
- KR-MF-000012193
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 8530b08e-cfdb-438f-8b92-8d5f0773423c 61 fields · synced Jun 18, 2026