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Maxi Haler NV 45 x 1.00 x 2.0
EUDAMEDClass IIa (EU MDR)
Ref 03-056-11Model DPI InhalerModel DPI inhaler
Identity
- Trade Name
- Maxi Haler NV 45 x 1.00 x 2.0 EUDAMED
- Device Name
- DPI Inhaler EUDAMEDMaxi Haler NV 45 x 1.00 x 2.0 EUDAMED
- Model / Reference
- DPI Inhaler EUDAMED03-056-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580208 EUDAMED
- Basic UDI-DI
- 789893558inhaler2N EUDAMEDB-07898935580208 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
Maxi Haler NV 45 x 1.00 x 2.0 by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class IIa — MDD, MDR — listed in EUDAMED
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 b94f2667-a6ae-47b7-909d-8e8ae057764e 61 fields · synced Jul 14, 2026
- EUDAMED 94553854-0b83-4348-827d-b4209e0a0e7c 61 fields · synced May 19, 2026