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PVC Manual Ventilation Balloon
EUDAMEDClass IIa (EU MDR)
Ref EMR0403001Model Adult, Pediatric, Infant
Identity
- Trade Name
- PVC Manual Ventilation Balloon EUDAMED
- Device Name
- PVC manual ventilation balloon EUDAMED
- Model / Reference
- Adult, Pediatric, Infant EUDAMEDEMR0403001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430415127 EUDAMED
- Basic UDI-DI
- 694643041336006N6 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
PVC Manual Ventilation Balloon by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — 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 | 694643041336006N6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED a7e77535-0e94-4e04-874a-9b53fc6b6746 61 fields · synced Jun 18, 2026