Identity
- Trade Name
- OneBreath EUDAMED
- Device Name
- OneBreath EUDAMED
- Model / Reference
- OneBreath EUDAMEDONEBREATH-MP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060246860245 EUDAMED
- Basic UDI-DI
- 506024686OB014W EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
OneBreath by Bedfont Scientific Ltd — 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 | 506024686OB014W | Class I | Active |
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Manufacturer
- Manufacturer
- Bedfont Scientific Ltd
- EUDAMED SRN
- GB-MF-000010889
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a5fc9229-d4aa-4d34-a788-d17a724aa697 61 fields · synced Jul 30, 2026