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Airmax

EUDAMED

Class I (EU MDR)

Ref AIR-7613Model 18-3366 / 2001958

by Aso Llc

Identity

Trade Name
Airmax EUDAMED
Device Name
Nasal Dilators Performance Black EUDAMED
Model / Reference
18-3366 / 2001958 EUDAMED
AIR-7613 EUDAMED

Identifiers

Primary DI / UDI-DI
08717438370439 EUDAMED
Basic UDI-DI
00172762001958AK 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 (1)

  • EUDAMED 4aa36752-00e3-41a6-a11c-ddf2f13edc6e 61 fields · synced Jun 19, 2026