Identity
- Trade Name
- Polaris HP S EUDAMED
- Device Name
- Laser therapy unit Polaris HP EUDAMED
- Model / Reference
- S, M EUDAMEDA-UL-AST-PHPS1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903641500661 EUDAMED
- Basic UDI-DI
- 590364150PHPKR EUDAMED
- Direct Marketing DI
- 05903641500661 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS 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
Polaris HP S 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 | 590364150PHPKR | Class IIb | Active |
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Manufacturer
- Manufacturer
- ASTAR spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000010564
Sources (1)
- EUDAMED 7f59229b-5e5d-4e66-834d-cd27d42b9339 61 fields · synced Oct 6, 2026