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Breathcare Management System
EUDAMEDClass IIa (EU MDR)
Ref NAModel Breathcare WEB Ⅱ
Identity
- Trade Name
- Breathcare Management System EUDAMED
- Model / Reference
- Breathcare WEB Ⅱ EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976363540016 EUDAMED
- Basic UDI-DI
- 6976363540016CL EUDAMED
- Direct Marketing DI
- 06976363540016 EUDAMED
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Breathcare Management System by Nanjing Yuyue Software Technology Co., Ltd. — 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 | 6976363540016CL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nanjing Yuyue Software Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000035086
- Authorised Representative
- Metrax GmbH DE-AR-000005481
Sources (1)
- EUDAMED 2703e3c4-69f5-4391-8280-31c43fe45461 61 fields · synced Jul 14, 2026