Identity
- Trade Name
- Impactis M+ EUDAMED
- Device Name
- Shock wave physiotherapy unit Impactis M+ EUDAMED
- Model / Reference
- A-UF-AST-IMM+ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903641500111 EUDAMED
- Basic UDI-DI
- 590364150IMM2C9 EUDAMED
- Direct Marketing DI
- 05903641500111 EUDAMED
- EMDN Code
- Z12139001 SHOCK WAVE THERAPY EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
Impactis M+ by ASTAR spółka z ograniczoną odpowiedzialnością — 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 | 590364150IMM2C9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- ASTAR spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000010564
Sources (1)
- EUDAMED d97fc03a-dae8-4734-b0f6-ba54b6de0a32 61 fields · synced Jun 20, 2026