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Vertical Haler 3.4mm NV - R
EUDAMEDClass I (EU MDR)
Ref 03-084-23Model DPI - INHALER Model DPI Inhaler
Identity
- Trade Name
- Vertical Haler 3.4mm NV - R EUDAMED
- Device Name
- Vertical Haler 3.4mm NV - R EUDAMEDDPI Inhaler EUDAMED
- Model / Reference
- DPI - INHALER EUDAMED03-084-23 EUDAMEDDPI Inhaler EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580185 EUDAMED
- Basic UDI-DI
- B-07898935580185 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
Vertical Haler 3.4mm NV - R by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class I — 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 | B-07898935580185 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-07898935580185 | 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 cbf36d9e-4a49-40fc-aa5f-9fdf53d322f6 61 fields · synced Jul 29, 2026
- EUDAMED f4736a18-dc84-4c14-8d97-0eedcfb1e25e 61 fields · synced May 17, 2026