Identity
- Trade Name
- Defibrillator monitor EUDAMED
- Device Name
- Defibrillator monitor EUDAMED
- Model / Reference
- S8 EUDAMEDS5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021257 EUDAMED
- Basic UDI-DI
- 69454290DM001K6 EUDAMED
- Direct Marketing DI
- 06945429021257 EUDAMED
- EMDN Code
- Z1203020201,Z12030501 EUDAMED
Classification
- Device Class
- Class III 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
Defibrillator monitor by Shenzhen Comen Medical Instruments Co., LTD. — Class III — 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 | 69454290DM001K6 | Class III | Active |
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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 61638053-c6d5-40a5-801b-f7238b2ec831 61 fields · synced Jun 18, 2026