Identity
- Trade Name
- Amabi EUDAMED
- Device Name
- Digital Thermometer EUDAMED
- Model / Reference
- DMT-437 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942284612460 EUDAMED
- Basic UDI-DI
- 6970392211MT00076F EUDAMED
- Direct Marketing DI
- 06942284612460 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Amabi by Joytech Healthcare 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 | 6970392211MT00076F | Class IIa | Active |
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Manufacturer
- Manufacturer
- JOYTECH Healthcare Co., Ltd.
- EUDAMED SRN
- CN-MF-000006020
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 47779197-fcbb-485b-aeaa-f9073d83cb56 61 fields · synced Jul 11, 2026