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Airmax
EUDAMEDClass I (EU MDR)
Ref AIR-7611Model 188964 / 18-3364Ref AIR-7612Model 188962 / 18-3362
by Aso Llc
Identity
- Trade Name
- Airmax EUDAMED
- Device Name
- Nasal Dilator Triple Bridge Clear P2S EUDAMEDNasal Dilator Triple Bridge Tan P2S EUDAMED
- Model / Reference
- 188964 / 18-3364 EUDAMEDAIR-7611 EUDAMED188962 / 18-3362 EUDAMEDAIR-7612 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717438376110 EUDAMED08717438376127 EUDAMED
- Basic UDI-DI
- 0017276188964S8 EUDAMED0017276188962S4 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Airmax by Aso LLC — 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 | 0017276188964S8 | Class I | Active |
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Manufacturer
- Manufacturer
- Aso Llc
- EUDAMED SRN
- US-MF-000008641
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (2)
- EUDAMED 18fcb063-d306-4594-9710-c60ad8d31f23 61 fields · synced Jul 31, 2026
- EUDAMED 83a7613a-4517-47cd-a2f9-c7d081010206 61 fields · synced May 17, 2026