Identity
- Device Name
- Breathing Trainer EUDAMED
- Model / Reference
- VP-BT05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970979575042 EUDAMED
- Basic UDI-DI
- 697097957VP-BTX7 EUDAMED
- EMDN Code
- R900902 INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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 Vapo Healthcare 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 | 697097957VP-BTX7 | Class I | Active |
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Manufacturer
- Manufacturer
- Vapo Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000014728
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 726fb592-cd30-4005-af85-4b475f716b46 61 fields · synced Jun 19, 2026