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pfm NeoBreathe CPAP Ventil
EUDAMEDClass I (EU MDR)
Ref NEONBModel Respiratory and Anaesthesia devices
Identity
- Trade Name
- pfm NeoBreathe CPAP Ventil EUDAMED
- Device Name
- NeoBreathe EUDAMED
- Model / Reference
- Respiratory and Anaesthesia devices EUDAMEDNEONB EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04042301207104 EUDAMED
- Basic UDI-DI
- 4042301R0280AASA EUDAMED
- Direct Marketing DI
- 04042301207104 EUDAMED
- EMDN Code
- R028001 RESPIRATORY CIRCUITS VALVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
pfm NeoBreathe CPAP Ventil by PFM medical mepro GmbH — Class I — 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 | 4042301R0280AASA | Class I | Active |
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Manufacturer
- Manufacturer
- PFM medical mepro GmbH
- EUDAMED SRN
- DE-MF-000005190
Sources (1)
- EUDAMED f7536d1f-14f7-4a8f-a0c9-4ab98aefaf8e 61 fields · synced Jul 11, 2026