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CDM Haler 2 x 1 x 2.25 -R
EUDAMEDClass IIa (EU MDR)
Ref 03-76515Model DPI InhalerModel DPI inhaler
Identity
- Trade Name
- CDM Haler 2 x 1 x 2.25 -R EUDAMED
- Device Name
- DPI Inhaler EUDAMEDCDM Haler 2 x 1 x 2.25 -R EUDAMED
- Model / Reference
- DPI Inhaler EUDAMED03-76515 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580543 EUDAMED
- Basic UDI-DI
- 789893558inhaler2N EUDAMEDB-07898935580543 EUDAMED
- EMDN Code
- R03010302 AEROSOL PORTABLE INHALERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Portugal EUDAMEDGermany 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 1 x 2.25 -R by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 789893558inhaler2N | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 789893558inhaler2N | Class IIa | 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 bb8e45bb-82f5-4934-9839-aeaf245fb2f9 61 fields · synced Jul 19, 2026
- EUDAMED cc77ae20-813c-469e-82c6-0a4ce053e94c 61 fields · synced May 17, 2026