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Silicone Manual Resuscitator
EUDAMEDClass IIa (EU MDR)
Ref EMR0103005Model LSIA-001/RTMA1、LSIA-001/RTMA2、 LSIA-002/RTMA2、LSIA-002/RTMA3、LSIA-003/RTMA2，LSIA-003/RTMA3、Infant,Pediatric,Adult
Identity
- Trade Name
- Silicone Manual Resuscitator EUDAMED
- Device Name
- Silicone Manual Resuscitator EUDAMED
- Model / Reference
- LSIA-001/RTMA1、LSIA-001/RTMA2、 LSIA-002/RTMA2、LSIA-002/RTMA3、LSIA-003/RTMA2，LSIA-003/RTMA3、Infant,Pediatric,Adult EUDAMEDEMR0103005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430419880 EUDAMED
- Basic UDI-DI
- 694643041759104R6 EUDAMED
- Direct Marketing DI
- 06946430419880 EUDAMED
- EMDN Code
- R03020201 MANUALLY OPERATED PULMONARY RESUSCITATORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Silicone Manual Resuscitator 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 | 694643041759104R6 | 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 3310a175-97ca-4e80-910f-80a87dd8bd89 61 fields · synced Jun 18, 2026