Identity
- Model / Reference
- IH 16 EUDAMED10351 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04211125103514 EUDAMED
- Basic UDI-DI
- 4211125IH16NL EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
10351 by Beurer GmbH — 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 | 4211125IH16NL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beurer GmbH
- EUDAMED SRN
- DE-MF-000005422
Sources (1)
- EUDAMED 562d3c96-7f62-417c-aa19-69b69ff54a01 61 fields · synced Oct 6, 2026