Identity
- Trade Name
- Gastrocheck Mouthpiece EUDAMED
- Device Name
- NObreath Mouthpiece EUDAMED
- Model / Reference
- GASTROCHECK-MP-50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060246860412 EUDAMED
- Basic UDI-DI
- 506024686MP016N EUDAMED
- EMDN Code
- R040101 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS 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
Category: Secretion suction kit
Gastrocheck Mouthpiece by Bedfont Scientific Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 3c95f36d-2612-413d-a8a3-612228db4e38 61 fields · synced Jul 8, 2026