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Airmax

EUDAMED

Class 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 EUDAMED
Nasal Dilator Triple Bridge Tan P2S EUDAMED
Model / Reference
188964 / 18-3364 EUDAMED
AIR-7611 EUDAMED
188962 / 18-3362 EUDAMED
AIR-7612 EUDAMED

Identifiers

Primary DI / UDI-DI
08717438376110 EUDAMED
08717438376127 EUDAMED
Basic UDI-DI
0017276188964S8 EUDAMED
0017276188962S4 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

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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