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CDM Haler 2 x 2 x 2.45
EUDAMEDClass I (EU MDR)
Ref 03-76430Model DPI inhalerModel DPI Inhaler
Identity
- Trade Name
- CDM Haler 2 x 2 x 2.45 EUDAMED
- Device Name
- CDM Haler 2 x 2 x 2.45 EUDAMEDDPI Inhaler EUDAMED
- Model / Reference
- DPI inhaler EUDAMED03-76430 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580307 EUDAMED
- Basic UDI-DI
- B-07898935580307 EUDAMED789893558inhaler2N EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMED
- Market of Registration
- Germany EUDAMEDPortugal 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 2.45 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-07898935580307 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07898935580307 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- BR-MF-000020354
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED 1d7ecea7-2aac-45ca-bf81-5064c4c7cf4e 61 fields · synced Jul 31, 2026
- EUDAMED 88857a52-ee69-4bb9-9feb-8aade71af4a3 61 fields · synced May 19, 2026