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Silicone manual ventilation balloon
EUDAMEDClass IIa (EU MDR)
Ref TM01-025-5Model Adult, Pediatric, InfantRef EMR0102001Ref TM01-025-6Ref TM01-025-4Ref EMR0103001Ref EMR0101001Ref EMR0107001Model Adult-H, Pediatric-H
Identity
- Trade Name
- Silicone manual ventilation balloon EUDAMED
- Device Name
- Silicone manual ventilation balloon EUDAMED
- Model / Reference
- Adult, Pediatric, Infant EUDAMEDTM01-025-5 EUDAMEDEMR0102001 EUDAMEDTM01-025-6 EUDAMEDTM01-025-4 EUDAMEDEMR0103001 EUDAMEDEMR0101001 EUDAMEDAdult-H, Pediatric-H EUDAMEDEMR0107001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430419422 EUDAMED06946430415073 EUDAMED06946430419439 EUDAMED06946430419415 EUDAMED06946430415080 EUDAMED06946430415066 EUDAMED06946430416353 EUDAMED
- Basic UDI-DI
- 694643041336005N4 EUDAMED694643041336007N8 EUDAMED
- Direct Marketing DI
- 06946430419422 EUDAMED06946430415073 EUDAMED06946430419439 EUDAMED06946430419415 EUDAMED06946430415080 EUDAMED06946430415066 EUDAMED06946430416353 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
Silicone 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.
- Ventlab — Ventlab Corp. · Class II
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- Ambu® SPUR® II Pediatric Resuscitator — Ambu A/S · Class II
- VT Sure — Pulmodyne Inc. · Class II
- 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 | 694643041336005N4 | 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 (7)
- EUDAMED eaf733fa-3f27-437b-b692-f27a0c82da97 61 fields · synced Jul 26, 2026
- EUDAMED 6f6ff0f6-aa09-4297-bec1-cbd4a03031c6 61 fields · synced May 17, 2026
- EUDAMED 94843ee6-b371-465b-9692-6af5d359a74b 61 fields · synced May 17, 2026
- EUDAMED d9d722ab-6c73-43b2-806a-3dacf7fa066f 61 fields · synced May 17, 2026
- EUDAMED 4824e63e-56ae-41eb-98cb-02310c3d2a48 61 fields · synced May 17, 2026
- EUDAMED cee5377d-918f-4b67-8a92-5c8f9a7560d8 61 fields · synced May 18, 2026
- EUDAMED 5fd2ffbd-1851-46c8-8254-a39423c3b1c9 61 fields · synced May 18, 2026