Identity
- Trade Name
- X105 Advanced (NE-C105-EO) EUDAMED
- Device Name
- Nebulizer EUDAMED
- Model / Reference
- NE-C105-EO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015672113237 EUDAMED
- Basic UDI-DI
- 803371701NEB354574R EUDAMED
- EMDN Code
- Z12159099 VARIOUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
X105 Advanced (NE-C105-EO) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- 3A HEALTH CARE S.r.l.
- EUDAMED SRN
- IT-MF-000009298
Sources (1)
- EUDAMED 8fbb0152-7d75-4ac0-848c-524b529bbaad 61 fields · synced Jul 12, 2026