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Infrared Thermometer
EUDAMEDClass IIa (EU MDR)
Ref REFModel BSX976Model BSX916Model BSX976、BSX916、BSX906
Identity
- Device Name
- Infrared Thermometer EUDAMED
- Model / Reference
- BSX976 EUDAMEDREF EUDAMEDBSX916 EUDAMEDBSX976、BSX916、BSX906 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06920485309761 EUDAMED06920485309167 EUDAMED06920485306012 EUDAMED06920485397607 EUDAMED06920485308139 EUDAMED
- Basic UDI-DI
- B-06920485309761 EUDAMEDB-06920485309167 EUDAMEDB-06920485306012 EUDAMEDB-06920485397607 EUDAMED69204853BSX976N3 EUDAMED
- Direct Marketing DI
- 06920485308139 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Infrared Thermometer by Shenzhen Bsx Technology Electronics Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06920485309761 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06920485309761 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Bsx Technology Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000015965
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (5)
- EUDAMED f008f07d-79ad-4453-a9e8-10de7e52ef7b 61 fields · synced Aug 4, 2026
- EUDAMED 849bfb86-bdc4-4aa8-a22d-be00dca69ab7 61 fields · synced May 17, 2026
- EUDAMED 392e4742-6380-4a8e-b4d7-4df732475131 61 fields · synced Jul 20, 2026
- EUDAMED 0dae705c-7f8f-432b-abd8-b0a8e4d6922d 61 fields · synced Jul 21, 2026
- EUDAMED c2909276-3e2b-49f5-b957-3bfbabf1bea6 61 fields · synced Jul 27, 2026