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b-good Infrared Ear Thermometer
EUDAMEDClass IIa (EU MDR)
Ref DET-1015Model DET
Identity
- Trade Name
- b-good Infrared Ear Thermometer EUDAMED
- Device Name
- Infrared Ear Thermometer EUDAMED
- Model / Reference
- DET EUDAMEDDET-1015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970392215907 EUDAMED
- Basic UDI-DI
- 6970392211ET00012T EUDAMED
- Direct Marketing DI
- 06970392215907 EUDAMED
- EMDN Code
- V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
b-good Infrared Ear Thermometer by Joytech Healthcare Co., Ltd. — Class IIa — 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 | 6970392211ET00012T | 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 (1)
- EUDAMED d8c86e66-0a66-4567-ae07-a1895b637506 61 fields · synced Jul 31, 2026