Identity
- Trade Name
- CPR System EUDAMED
- Device Name
- Cardiopulmonary resuscitator (CPR system) EUDAMED
- Model / Reference
- E5, E6, E7, E8 EUDAMED211B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970658141025 EUDAMED
- Basic UDI-DI
- 69706581400189V EUDAMED
- EMDN Code
- Z120304 CARDIAC COMPRESSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
CPR System by Ambulanc(Shenzhen)Tech.Co., Ltd. — Class IIb — 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 | 69706581400189V | Class IIb | Active |
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Manufacturer
- Manufacturer
- Ambulanc(Shenzhen)Tech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010435
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED dc187445-1d99-41c5-a242-4fb675e98ade 61 fields · synced Jun 18, 2026