← Back to catalogue
Maxi Haler NV 45 x 1.00 x 4.4 - R
EUDAMEDClass I (EU MDR)
Ref 03-056-00Model DPI inhalerModel DPI Inhaler
Identity
- Trade Name
- Maxi Haler NV 45 x 1.00 x 4.4 - R EUDAMED
- Device Name
- Maxi Haler NV 45 x 1.00 x 4.4 - R EUDAMEDDPI Inhaler EUDAMED
- Model / Reference
- DPI inhaler EUDAMED03-056-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580352 EUDAMED
- Basic UDI-DI
- B-07898935580352 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
Maxi Haler NV 45 x 1.00 x 4.4 - R by Emphasys Importadora, Exportadora E Distribuidora Ltda. — Class I — MDR, MDD — listed in EUDAMED
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-07898935580352 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07898935580352 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- BR-MF-000020354
- Authorised Representative
- Cinterqual-Soluções de Comércio Internacional,Lda. PT-AR-000002813
Sources (2)
- EUDAMED daf3e0cf-dc77-4ea4-bf65-a8fc841fab2e 61 fields · synced Jun 19, 2026
- EUDAMED 615fda47-b643-41a8-8125-8d886bc178b9 61 fields · synced May 17, 2026