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Infrared Ear Thermometer
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref DET-1215Ref DET-1115Ref DET-1015Model DETRef DET-1013Ref DET-1115b，DET-1215bRef DET-1015bRef DET-1025
Identity
- Trade Name
- Infrared Ear Thermometer EUDAMED
- Device Name
- Infrared Ear Thermometer EUDAMED
- Model / Reference
- DET-1215 EUDAMEDDET-1115 EUDAMEDDET EUDAMEDDET-1015 EUDAMEDDET-1013 EUDAMEDDET-1115b，DET-1215b EUDAMEDDET-1015b EUDAMEDDET-1025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392219448 EUDAMED06970392219424 EUDAMED06970392215938 EUDAMED06970392219387 EUDAMED06970392219431 EUDAMED06970392219370 EUDAMED06970392214498 EUDAMED
- Basic UDI-DI
- 6970392211ET00032X EUDAMED6970392211ET00012T EUDAMED6970392211ET00042Z EUDAMED6970392211ET00022V EUDAMED
- Direct Marketing DI
- 06970392219448 EUDAMED06970392219424 EUDAMED06970392215938 EUDAMED06970392219387 EUDAMED06970392219431 EUDAMED06970392219370 EUDAMED06970392214498 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDFrance 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 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181081 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 6970392211ET00032X | 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 (8)
- EUDAMED 507f5b28-8b2a-420f-9920-caf3560c0812 61 fields · synced Aug 3, 2026
- EUDAMED fb6f787f-b7ef-45c0-aebd-3e0dbb3cd3a1 61 fields · synced May 11, 2026
- EUDAMED d50443e0-11c9-46d7-9e6a-bdcdef285bcc 61 fields · synced May 16, 2026
- EUDAMED af1e0e09-6fd1-4d9b-a66f-882c12603264 61 fields · synced May 17, 2026
- EUDAMED 36f38db4-bf83-417a-a301-d910942fd3a5 61 fields · synced May 18, 2026
- EUDAMED 4a781343-9867-460f-a9bf-c2cd8cea1b51 61 fields · synced May 19, 2026
- EUDAMED 10fb832b-2267-41c9-998a-6d2a5dddd1e4 61 fields · synced Jul 26, 2026
- FDA 510(k) K181081 1 fields · synced May 18, 2026