Identity
- Trade Name
- DuoBaby (NE-C301-UK) EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- NE-C301-UK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672110373 EUDAMED
- Basic UDI-DI
- 803371701NEB354574R EUDAMED
- EMDN Code
- Z12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
DuoBaby (NE-C301-UK) by 3A HEALTH CARE S.r.l. — 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 | 803371701NEB354574R | Class IIa | Active |
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Manufacturer
- Manufacturer
- 3A HEALTH CARE S.r.l.
- EUDAMED SRN
- IT-MF-000009298
Sources (1)
- EUDAMED 6ebe906e-8bb7-4c44-8b80-bdd43ed98e32 61 fields · synced Jul 11, 2026