Identity
- Trade Name
- Automatic CPR Machine EUDAMED
- Device Name
- Automatic CPR Machine EUDAMED
- Model / Reference
- ES5 EUDAMEDES3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429060751 EUDAMED
- Basic UDI-DI
- 69454290AC001FX EUDAMED
- Direct Marketing DI
- 06945429060751 EUDAMED
- EMDN Code
- C020499 EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER 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
Automatic CPR Machine by Shenzhen Comen Medical Instruments 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 | 69454290AC001FX | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED b6d81409-cfa9-4bff-81e5-bac01b38a6a3 61 fields · synced Jun 19, 2026