Identity
- Trade Name
- SIMZO EUDAMED
- Device Name
- Clinical Digital Thermometer EUDAMED
- Model / Reference
- TH-802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959989100185 EUDAMED
- Basic UDI-DI
- B-06959989100185 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Simzo by Dongguan SIMZO Electronic Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06959989100185 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan SIMZO Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015642
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 45224378-c10d-4228-aa9f-21ace19b647e 61 fields · synced Oct 5, 2026