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Temperature Probes
EUDAMEDClass I (EU MDR)
Ref A-TP-13Ref A-TP-10Ref MDRRef A-HP-03Ref A-10-03Ref A-SS-03Ref A-TP-11Ref A-LB-03-01
Identity
- Trade Name
- Temperature Probes EUDAMED
- Device Name
- Temperature Probes EUDAMED
- Model / Reference
- A-TP-13 EUDAMEDA-TP-10 EUDAMEDMDR EUDAMEDA-HP-03 EUDAMEDA-10-03 EUDAMEDA-SS-03 EUDAMEDA-TP-11 EUDAMEDA-LB-03-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946725529997 EUDAMED06946725529966 EUDAMED06946725523230 EUDAMED06946725523193 EUDAMED06946725547441 EUDAMED06946725523155 EUDAMED06946725529973 EUDAMED06946725500859 EUDAMED06946725541067 EUDAMED
- Basic UDI-DI
- 69467255A-Tempe6M EUDAMED
- EMDN Code
- Z12062403 TEMPERATURE BIOFEEDBACK SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMEDSpain EUDAMEDGermany 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 Probes 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 (9)
- EUDAMED f5880c7c-36e5-4d8a-8daf-fdbadfcb4491 61 fields · synced Jul 27, 2026
- EUDAMED 69d2743b-1ca1-4d6d-b4f9-a151b6957721 61 fields · synced May 16, 2026
- EUDAMED 212b88b9-0c98-4605-bb40-8b5172b9d2e6 61 fields · synced May 17, 2026
- EUDAMED de3df0f9-71d8-45f8-a39f-2b1efb305ba5 61 fields · synced May 17, 2026
- EUDAMED bb440bf3-ae64-449b-b5b3-43dadc9cf52e 61 fields · synced May 18, 2026
- EUDAMED 3267f5d9-4ee0-4c6b-ab6b-920a850754af 61 fields · synced May 18, 2026
- EUDAMED 54d41915-b739-4655-91d6-be73192c5de8 61 fields · synced May 18, 2026
- EUDAMED 8e449ead-b695-44e7-ba6a-17f3c07adff6 61 fields · synced May 19, 2026
- EUDAMED 1a4042c3-7b90-491b-a72a-e9f3dabf9916 61 fields · synced May 19, 2026