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EU dreamTAP kit
EUDAMEDClass I (EU MDR)
Ref DE/CA09/00144894Model TAP Oral Appliance
Identity
- Trade Name
- EU dreamTAP kit EUDAMED
- Device Name
- customTAP EUDAMED
- Model / Reference
- TAP Oral Appliance EUDAMEDDE/CA09/00144894 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00851085006155 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
- France 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
EU dreamTAP kit by Airway Management Inc — 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 | 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 (1)
- EUDAMED 3e549a3f-583d-4c26-b5ed-a3952952b564 61 fields · synced Jul 23, 2026