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Silicone Manual Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref EMR0107002Model Pediatric-H
Identity
- Trade Name
- Silicone Manual Resuscitator EUDAMED
- Device Name
- Silicone manual resuscitator EUDAMED
- Model / Reference
- Pediatric-H EUDAMEDEMR0107002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430421982 EUDAMED
- Basic UDI-DI
- 694643041759121R6 EUDAMED
- Direct Marketing DI
- 06946430421982 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia 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 Resuscitator 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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- 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 | 694643041759121R6 | 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 19b89db5-d16e-4c91-b344-4a92fd57c866 61 fields · synced Jun 18, 2026