Identity
- Trade Name
- UBREATH® EUDAMED
- Device Name
- OPEP and Inspiratory Muscle Training Device EUDAMED
- Model / Reference
- PE400 EUDAMEDPE4002101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26971404132759 EUDAMED
- Basic UDI-DI
- 69714041300193Y EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Ubreath® by E-Linkcare Meditech Co., Ltd. — 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 | 69714041300193Y | Class I | Active |
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Manufacturer
- Manufacturer
- e-LinkCare Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000019475
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 744f615f-a40f-47c5-8604-b34d8de3ad57 61 fields · synced Jun 19, 2026