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Nasal Continuous Positive Airway Pressure System
EUDAMEDClass IIa (EU MDR)
Ref 68B
Identity
- Trade Name
- Nasal Continuous Positive Airway Pressure System EUDAMED
- Device Name
- Nasal Continuous Positive Airway Pressure System EUDAMED
- Model / Reference
- 68B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970658140196 EUDAMED
- Basic UDI-DI
- B-06970658140196 EUDAMED
- EMDN Code
- Z1203010503 NEONATAL/PAEDIATRIC PULMONARY VENTILATORS 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Nasal Continuous Positive Airway Pressure System by Ambulanc(Shenzhen)Tech.Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970658140196 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ambulanc(Shenzhen)Tech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010435
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 27eaa626-b3a2-4623-93f6-47e1dae5d089 61 fields · synced Oct 6, 2026