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Disposable Temperature probe
EUDAMEDClass I (EU MDR)
Ref A-DYS-02Ref A-DOM-02-01Ref A-DYS-01Ref A-DYS-03Ref A-DDR-03-02Ref A-DDC-02Ref A-DYS-01-02Ref A-DDC-01Ref A-DOM-01
Identity
- Trade Name
- Disposable Temperature probe EUDAMED
- Device Name
- Temperature Probes EUDAMED
- Model / Reference
- A-DYS-02 EUDAMEDA-DOM-02-01 EUDAMEDA-DYS-01 EUDAMEDA-DYS-03 EUDAMEDA-DDR-03-02 EUDAMEDA-DDC-02 EUDAMEDA-DYS-01-02 EUDAMEDA-DDC-01 EUDAMEDA-DOM-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946725530153 EUDAMED06946725545348 EUDAMED06946725530146 EUDAMED06946725530160 EUDAMED06946725503416 EUDAMED06946725530184 EUDAMED06946725500804 EUDAMED06946725530177 EUDAMED06946725530207 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
Disposable 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 (9)
- EUDAMED fc421068-0e87-42ef-9285-0cf69ae7c549 61 fields · synced Sep 18, 2026
- EUDAMED 6a8b0690-ad70-4d93-bffe-e78b94f43fc6 61 fields · synced May 17, 2026
- EUDAMED e3486123-76cd-4fba-b9da-321e6b0f4df7 61 fields · synced May 17, 2026
- EUDAMED baab13d3-aa92-43e0-b5d0-d08b5329b045 61 fields · synced May 17, 2026
- EUDAMED 65fa5515-ec13-4ac0-a011-9fdcb8519138 61 fields · synced May 17, 2026
- EUDAMED 68ee8b23-0835-40d9-8459-cd8a8e59921a 61 fields · synced May 18, 2026
- EUDAMED 00f2cb99-b16c-4b09-b4cd-ea6901dd3c1f 61 fields · synced May 18, 2026
- EUDAMED 4a2a030c-01ce-45ac-af7c-53f07a87a467 61 fields · synced May 18, 2026
- EUDAMED 32ad49af-7231-49f5-a7b4-48ae432b9816 61 fields · synced May 18, 2026