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Dual Haler - DH 0.8 - R - TP - ABS
EUDAMEDClass I (EU MDR)
Ref 03-118-25Model DPI inhalerModel DPI Inhaler
Identity
- Trade Name
- Dual Haler - DH 0.8 - R - TP - ABS EUDAMED
- Device Name
- Dual Haler - DH 0.8 - R - TP - ABS EUDAMEDDPI Inhaler EUDAMED
- Model / Reference
- DPI inhaler EUDAMED03-118-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07898935580321 EUDAMED
- Basic UDI-DI
- B-07898935580321 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
Dual Haler - DH 0.8 - R - TP - ABS 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-07898935580321 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-07898935580321 | 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 f9097432-5226-49b7-b5f6-7a75c4628ebd 61 fields · synced Jul 16, 2026
- EUDAMED 5ea2fba0-8f36-48d2-ab13-3a0774d73028 61 fields · synced May 19, 2026