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Breathing Trainer
EUDAMEDClass I (EU MDR)
Ref VIS-09Ref 31266Model VIS-01Ref VIS-07
Identity
- Trade Name
- BREATHING TRAINER EUDAMED
- Device Name
- Breathing Trainer EUDAMED
- Model / Reference
- VIS-09 EUDAMEDVIS-01 EUDAMED31266 EUDAMEDVIS-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973280040131 EUDAMED06973280040025 EUDAMED06973280043231 EUDAMED
- Basic UDI-DI
- 697328004VIS-09KB EUDAMED697328004VIS-01JT EUDAMED697328004VIS-07K7 EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Breathing Trainer by Hui Zhou Kaiyi Technology Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Breathing Trainer
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 | 697328004VIS-09KB | Class I | Active |
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Manufacturer
- Manufacturer
- Hui Zhou Kaiyi Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000010394
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (3)
- EUDAMED e31f182d-0f8c-4090-8b6e-cca430f3f962 61 fields · synced Aug 4, 2026
- EUDAMED 03802eb5-6386-471b-a75a-25c18804e0a5 61 fields · synced May 17, 2026
- EUDAMED 475e4e78-3383-45d7-b65e-1e3a972b7981 61 fields · synced May 18, 2026