Identity
- Trade Name
- Breathing Trainer EUDAMED
- Device Name
- Breathing Trainer EUDAMED
- Model / Reference
- KH-001 EUDAMEDKH-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941730282790 EUDAMED06941730282806 EUDAMED
- Basic UDI-DI
- 69417302KH-0019A EUDAMED69417302KH-0029C EUDAMED
- Direct Marketing DI
- 06941730282790 EUDAMED06941730282806 EUDAMED
- EMDN Code
- R0599 RESPIRATORY DEVICES, SUCTION AND DILATION SYSTEMS - OTHER 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 Nanchang Kanghua Health Materials 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 | 69417302KH-0019A | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nanchang Kanghua Health Materials Co., Ltd
- EUDAMED SRN
- CN-MF-000014308
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 3795114c-45a2-448d-be13-81067b5c0f59 61 fields · synced Oct 6, 2026
- EUDAMED 8b5505b0-951d-4095-b93a-81f723b4c717 61 fields · synced May 18, 2026