Identity
- Trade Name
- ELYSIUM EUDAMED
- Device Name
- Mercury free clinical thermometer EUDAMED
- Model / Reference
- MC-10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970691000990 EUDAMED
- Basic UDI-DI
- 697069100MC003AL EUDAMED
- EMDN Code
- V03010104 LIQUID EXPANSION THERMOMETERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Hungary 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
Elysium by Wuxi Exanovo Medical Instrument Co., Ltd. — Class I — 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 | 697069100MC003AL | Class I | Active |
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Manufacturer
- Manufacturer
- Wuxi Exanovo Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000021396
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 73fa64af-2b3a-42ee-ab8c-de6f7c157a28 61 fields · synced Oct 6, 2026