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BreathCare+ APP Ι
EUDAMEDClass I (EU MDR)
Ref BR-BreathCare+ APP Ι-EUModel BreathCare+ APP Ι
Identity
- Trade Name
- BreathCare+ APP Ι EUDAMED
- Device Name
- BreathCare+ EUDAMED
- Model / Reference
- BreathCare+ APP Ι EUDAMEDBR-BreathCare+ APP Ι-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976363540023 EUDAMED
- Basic UDI-DI
- 6976363540023CH EUDAMED
- EMDN Code
- Z12030292 VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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+ APP Ι by Nanjing Yuyue Software Technology 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 | 6976363540023CH | Class I | 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 773a4af0-95d1-4ff4-9391-4774dd3508bd 61 fields · synced Jun 19, 2026