Identity
- Device Name
- BreathCare Station EUDAMED
- Model / Reference
- BR-BreathCare Station-EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06976363540047 EUDAMED
- Basic UDI-DI
- 6976363540047CX 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 Station 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 | 6976363540047CX | 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 9d8d358b-25f6-4412-98e6-28dfc2498b96 61 fields · synced Jun 18, 2026