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CDA Haler 45 x 1.00 x 3.5 - O - V1 - R

EUDAMED

Class I (EU MDR)

Ref 03-085-41Model DPI inhalerModel DPI Inhaler

by Emphasys Importadora, Exportadora E Distribuidora Ltda.

Identity

Trade Name
CDA Haler 45 x 1.00 x 3.5 - O - V1 - R EUDAMED
Device Name
CDA Haler 45 x 1.00 x 3.5 - O - V1 - R EUDAMED
DPI Inhaler EUDAMED
Model / Reference
DPI inhaler EUDAMED
03-085-41 EUDAMED

Identifiers

Primary DI / UDI-DI
07898935580581 EUDAMED
Basic UDI-DI
B-07898935580581 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

CDA Haler 45 x 1.00 x 3.5 - O - V1 - R by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class I — MDR, MDD — listed in EUDAMED

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 d94b3f4b-ae66-4b20-94c6-6c4a2ffc0c2b 61 fields · synced Jul 9, 2026
  • EUDAMED cb026ce9-d6bc-44f4-a6f3-cac02463eb8f 61 fields · synced May 19, 2026