Identity
- Trade Name
- AMK Breathing trainer EUDAMED
- Device Name
- Breathing trainer EUDAMED
- Model / Reference
- 7000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972444528348 EUDAMED
- Basic UDI-DI
- 69724445283WV EUDAMED
- Direct Marketing DI
- 06972444528348 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
AMK Breathing trainer by Guangzhou AMK Medical Equipment 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 | 69724445283WV | Class I | Active |
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Manufacturer
- Manufacturer
- Guangzhou AMK Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000045752
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b9b264c3-23b9-49c6-8e4c-aab4bab07302 61 fields · synced Oct 6, 2026