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Dual Haler DH - 0.8 - R - TP - ABS - NV - II
EUDAMEDClass IIa (EU MDR)
Ref 03-118-31Model DPI InhalerModel DPI inhaler
Identity
- Trade Name
- Dual Haler DH - 0.8 - R - TP - ABS - NV - II EUDAMED
- Device Name
- DPI Inhaler EUDAMEDDual Haler DH - 0.8 - R - TP - ABS - NV - II EUDAMED
- Model / Reference
- DPI Inhaler EUDAMED03-118-31 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580499 EUDAMED
- Basic UDI-DI
- 789893558inhaler2N EUDAMEDB-07898935580499 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
Dual Haler DH - 0.8 - R - TP - ABS - NV - II 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 38bd5d7b-2d8b-4c2a-948d-47769444cf7e 61 fields · synced Jul 19, 2026
- EUDAMED cf120e58-89f1-4773-aa3f-4e62dc1e4c52 61 fields · synced May 19, 2026