Identity
- Trade Name
- Temperature probe EUDAMED
- Device Name
- Temperature Probes EUDAMED
- Model / Reference
- A-GE-01-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946725500507 EUDAMED
- Basic UDI-DI
- 69467255A-Tempe6M EUDAMED
- EMDN Code
- Z12062403 TEMPERATURE BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Temperature probe by APK Technology 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 | 69467255A-Tempe6M | Class I | Active |
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Manufacturer
- Manufacturer
- APK Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000011581
- Authorised Representative
- Ruiyi Healthcare GmbH DE-AR-000005962
Sources (1)
- EUDAMED af14dfa3-f429-412f-ae20-7dc5a3be16df 61 fields · synced Jun 19, 2026