Identity
- Device Name
- Mouthpiece EUDAMED
- Model / Reference
- M1 EUDAMEDICU M1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934325307299 EUDAMED26934325305497 EUDAMED
- Basic UDI-DI
- 69343253R900134A4B EUDAMED
- Direct Marketing DI
- 06934325307299 EUDAMED26934325305497 EUDAMED
- EMDN Code
- R9001 RESPIRATORY MOUTHPIECES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mouthpiece by Feellife Health Inc. — Class IIa — 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 | 69343253R900134A4B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Feellife Health Inc.
- EUDAMED SRN
- CN-MF-000000782
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 0b54e403-87b5-4428-9590-839fb33e9e3f 61 fields · synced Jul 18, 2026
- EUDAMED c105cb47-8e72-483c-922d-3f335949e0bb 61 fields · synced May 18, 2026