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Asepta Sports Akileine Ice Spray
EUDAMEDClass IIa (EU MDR)
Ref AF18430FRA
by TOSVAR srl
Identity
- Trade Name
- ASEPTA SPORTS AKILEINE ICE SPRAY EUDAMED
- Device Name
- ASEPTA SPORTS AKILEINE SPRAY FROID INTENSE EUDAMED
- Model / Reference
- AF18430FRA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08028356000927 EUDAMED
- Basic UDI-DI
- 8028356SSICE01L7L EUDAMED
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Hot/cold therapy pack, reusable
Asepta Sports Akileine Ice Spray by TOSVAR srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Hot/cold therapy pack, reusable.
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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 | 8028356SSICE01L7L | Class IIa | Active |
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Manufacturer
- Manufacturer
- TOSVAR srl
- EUDAMED SRN
- IT-MF-000013303
Sources (1)
- EUDAMED aabce723-1797-4cc7-b6d0-3d60403b7878 61 fields · synced Jun 19, 2026