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PRO-115 Medical nebulizer
EUDAMEDClass IIa (EU MDR)
Ref 1101224Model MED-120, PRO-110, PRO-115, TH-130, MED-111, MED-130
Identity
- Trade Name
- PRO-115 Medical nebulizer EUDAMED
- Device Name
- Compressor nebulizer EUDAMED
- Model / Reference
- MED-120, PRO-110, PRO-115, TH-130, MED-111, MED-130 EUDAMED1101224 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640156393118 EUDAMED
- Basic UDI-DI
- 764015639MDA0307_1M8 EUDAMED
- Direct Marketing DI
- 07640156393118 EUDAMED
- EMDN Code
- Z12159002 AEROSOL EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PRO-115 Medical nebulizer by B.Well Swiss AG — 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 | 764015639MDA0307_1M8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- B.Well Swiss AG
- EUDAMED SRN
- CH-MF-000012588
- Authorised Representative
- Blue Broccoli GmbH LI-AR-000000233
Sources (1)
- EUDAMED 7f0af03b-6468-4783-ae7c-42d7b72cb5b9 61 fields · synced Jun 18, 2026