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PVC Manual Ventilation Balloon
EUDAMEDClass IIa (EU MDR)
Ref EMR0406001Model Adult-H, Pediatric-H
Identity
- Trade Name
- PVC Manual Ventilation Balloon EUDAMED
- Device Name
- PVC manual ventilation balloon EUDAMED
- Model / Reference
- Adult-H, Pediatric-H EUDAMEDEMR0406001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430416322 EUDAMED
- Basic UDI-DI
- 694643041336008NA 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
Category: Pulmonary resuscitator, manual, single-use
PVC Manual Ventilation Balloon by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, manual, single-use.
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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- SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator — Ambu A/S · Class II
- Ventlab — Ventlab Corp. · Class I
- Ventlab — Ventlab Corp. · Class II
- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
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 | 694643041336008NA | 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 5fe8e68e-9f10-400b-9a3c-649419a02d1f 61 fields · synced Jun 19, 2026