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Infrared Ear/Forehead Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DET-2130(TSO672)Ref DET-2129Ref DET-2126b，DET-2129b，DET-2133bRef DET-215
Identity
- Trade Name
- Infrared Ear/Forehead Thermometer EUDAMED
- Device Name
- Infrared Ear/Forehead Thermometer EUDAMEDInfrared Forehead Thermometer EUDAMED
- Model / Reference
- DET-2130(TSO672) EUDAMEDDET-2129 EUDAMEDDET-2126b，DET-2129b，DET-2133b EUDAMEDDET-215 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942284619025 EUDAMED06942284605974 EUDAMED06970392217079 EUDAMED06970392214481 EUDAMED
- Basic UDI-DI
- 6970392211ET00102U EUDAMED6970392211ET00112W EUDAMED
- Direct Marketing DI
- 06942284619025 EUDAMED06942284605974 EUDAMED06970392217079 EUDAMED06970392214481 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDFrance EUDAMEDDenmark 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
Infrared Ear/Forehead Thermometer by Joytech Healthcare Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190873 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181239 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211ET00102U | 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 (5)
- EUDAMED 54ccf7cf-2c68-42be-accf-05cacc1e5eed 61 fields · synced Sep 18, 2026
- EUDAMED c819e1c7-2310-4f49-8e8e-3879851f0f0a 61 fields · synced May 18, 2026
- EUDAMED b5cde172-8d17-45d6-89bb-c1bf34f14b06 61 fields · synced May 18, 2026
- EUDAMED bef8bba1-7052-462a-862e-abdceb0a2c2e 61 fields · synced May 18, 2026
- FDA 510(k) K190873 1 fields · synced May 18, 2026