Identity
- Trade Name
- SteriBreath Eco Mouthpiece EUDAMED
- Device Name
- NObreath Mouthpiece EUDAMED
- Model / Reference
- STERIBREATH-ECO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060246860474 EUDAMED
- Basic UDI-DI
- 506024686MP016N EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
SteriBreath Eco Mouthpiece 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 | 506024686MP016N | 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 08a039bc-2d18-426e-882f-e55dfa9e1ad5 61 fields · synced Jun 19, 2026