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myTAP oral oral appliance pack of 10 CE
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref DE/CA09/00144894Model TAP Oral Appliance
Identity
- Trade Name
- myTAP oral oral appliance pack of 10 CE EUDAMED
- Device Name
- customTAP EUDAMED
- Model / Reference
- TAP Oral Appliance EUDAMEDDE/CA09/00144894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10851085006176 EUDAMED
- Basic UDI-DI
- 0851085006100SV EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
myTAP oral oral appliance pack of 10 CE by Airway Management Inc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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 | K181482 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0851085006100SV | Class I | Active |
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Manufacturer
- Manufacturer
- Airway Management Inc
- EUDAMED SRN
- US-MF-000039267
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED ca19a333-c261-4e51-a39b-0676cee37d77 61 fields · synced Oct 6, 2026
- FDA 510(k) K181482 1 fields · synced May 18, 2026