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nubulizer chamber
EUDAMEDClass IIa (EU MDR)
Ref PN100Model PN100,Prolife NA10,Pempa NEB500, IN 525,IN A50 AGU N8,Prolife PN Mesh PN600,Pro Mesh, AGU SN10,Prolife PN Smart
Identity
- Trade Name
- nubulizer chamber EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- PN100,Prolife NA10,Pempa NEB500, IN 525,IN A50 AGU N8,Prolife PN Mesh PN600,Pro Mesh, AGU SN10,Prolife PN Smart EUDAMEDPN100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158400812 EUDAMED
- Basic UDI-DI
- 69481584NEB01SX EUDAMED
- Direct Marketing DI
- 06948158400812 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
nubulizer chamber by Shenzhen Combei 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 | 69481584NEB01SX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Combei Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000016047
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 89382a9a-410b-4b48-8ee9-aeaf71a6e30b 61 fields · synced Oct 6, 2026