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Nebulizer
EUDAMEDClass IIa (EU MDR)
Ref PN100 (PEMPA NEB500)Model PN100,Prolife NA10,Pempa NEB500, IN 525,IN A50 AGU N8,Prolife PN Mesh PN600,Pro Mesh, AGU SN10,Prolife PN SmartRef PN100Ref PN100(IN 525)
Identity
- Trade Name
- Nebulizer 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 (PEMPA NEB500) EUDAMEDPN100 EUDAMEDPN100(IN 525) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948158405213 EUDAMED06948158400782 EUDAMED06948158405220 EUDAMED
- Basic UDI-DI
- 69481584NEB01SX EUDAMED
- Direct Marketing DI
- 06948158405213 EUDAMED06948158400782 EUDAMED06948158405220 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMEDGermany 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
Nebulizer 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 (3)
- EUDAMED 016fc3c5-c3eb-422a-b475-894bf60cc210 61 fields · synced Oct 6, 2026
- EUDAMED 3a32b59b-4631-4174-ae71-f6934706af5a 61 fields · synced May 17, 2026
- EUDAMED 56f88d20-21a4-44ec-8be9-e29b858d8794 61 fields · synced May 18, 2026