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PVC Manual Ventilation Balloon
EUDAMEDClass IIa (EU MDR)
Ref EMR0407001Model Adult-H, Pediatric-HRef TM01-026-6Model Adult, Pediatric, InfantRef EMR0402001Ref TM01-026-5Ref EMR0401001Ref TM01-026-4
Identity
- Trade Name
- PVC Manual Ventilation Balloon EUDAMED
- Device Name
- PVC manual ventilation balloon EUDAMED
- Model / Reference
- Adult-H, Pediatric-H EUDAMEDEMR0407001 EUDAMEDAdult, Pediatric, Infant EUDAMEDTM01-026-6 EUDAMEDEMR0402001 EUDAMEDTM01-026-5 EUDAMEDEMR0401001 EUDAMEDTM01-026-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430416339 EUDAMED06946430419477 EUDAMED06946430415110 EUDAMED06946430419460 EUDAMED06946430415103 EUDAMED06946430419453 EUDAMED
- Basic UDI-DI
- 694643041336008NA EUDAMED694643041336006N6 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 | 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 (6)
- EUDAMED 0c1dbb3c-6a81-49dd-9681-ed822c049e59 61 fields · synced Jul 27, 2026
- EUDAMED a15c5df4-c088-49dd-934c-24ada83b5108 61 fields · synced May 16, 2026
- EUDAMED b479129b-db02-4158-81f4-f30a69687f91 61 fields · synced May 17, 2026
- EUDAMED 3d24271a-b4f3-4fe1-94ea-57cc17fd13b4 61 fields · synced May 18, 2026
- EUDAMED 262ea1b3-5765-47e6-be2e-797092ad6123 61 fields · synced May 19, 2026
- EUDAMED 672346ad-91a1-4a44-80a0-d4e628e7282f 61 fields · synced May 19, 2026