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CDM Haler 2 x 2 x 2.25

EUDAMED

Class I (EU MDR)

Ref 03-76429Model DPI inhalerModel DPI Inhaler

by Emphasys Importadora, Exportadora E Distribuidora Ltda.

Identity

Trade Name
CDM Haler 2 x 2 x 2.25 EUDAMED
Device Name
CDM Haler 2 x 2 x 2.25 EUDAMED
DPI Inhaler EUDAMED
Model / Reference
DPI inhaler EUDAMED
03-76429 EUDAMED

Identifiers

Primary DI / UDI-DI
07898935580574 EUDAMED
Basic UDI-DI
B-07898935580574 EUDAMED
789893558inhaler2N EUDAMED
EMDN Code
R03010302 AEROSOL PORTABLE INHALERS EUDAMED

Classification

Device Class
Class I EUDAMED
Class IIa EUDAMED
Market of Registration
Germany EUDAMED
Portugal 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

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

CDM Haler 2 x 2 x 2.25 by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Emphasys Importadora, Exportadora E Distribuidora Ltda.
EUDAMED SRN
BR-MF-000020354
Authorised Representative
Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813

Sources (2)

  • EUDAMED f93f7cf6-6c5c-46e7-bc2d-cb0e848b64fd 61 fields · synced Jun 19, 2026
  • EUDAMED caa05bb9-5124-4b4c-a907-6e1bee498650 61 fields · synced May 19, 2026