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NObreath Mouthpiece
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref NOBREATH-V2-MP50Ref NTK-50/NTK100/NTK300/NTK/1000
Identity
- Trade Name
- NObreath Mouthpiece EUDAMED
- Device Name
- NObreath Mouthpiece EUDAMED
- Model / Reference
- NOBREATH-V2-MP50 EUDAMEDNTK-50/NTK100/NTK300/NTK/1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060246860191 EUDAMED05060246860405 EUDAMED
- Basic UDI-DI
- 506024686MP016N EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMEDDenmark 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
Category: Secretion suction kit
NObreath Mouthpiece by Bedfont Scientific Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203695 | Class I | Active |
| 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 (3)
- EUDAMED 2447a714-165e-4765-8e73-deadde2fecf6 61 fields · synced Aug 4, 2026
- EUDAMED 7f8ed45e-d5e5-4c83-871e-8aa9c5a9dbec 61 fields · synced May 18, 2026
- FDA 510(k) K203695 1 fields · synced May 18, 2026