Identity
- Device Name
- Dry Powder Inhaler EUDAMED
- Model / Reference
- DPI-1 EUDAMED1001070001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26976262370008 EUDAMED
- Basic UDI-DI
- 697626237DPI10K3 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Dry Powder Inhaler by Shenzhen Bona Pharma Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697626237DPI10K3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Bona Pharma Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000017363
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED cccb91c3-8566-4ccb-9442-c5d43eaa217b 61 fields · synced Jun 18, 2026