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One Medical
EUDAMEDClass IIa (EU MDR)
Ref JXB308+5AC041Model JXB-178, JXB-182, JXB-183, JXB-311, JXB-315, JXB-319, BL-6001, JXB-180, JXB-195, JXB-190, JXB-192, JA001, JXB-301, JXB-302, JXB-182B, JXB-308, JXB-320, LMP001, EW-TA50, EW-TA51Ref 0DT008+1AC003Model DT007, DT008, DT113, DT116, DT117, DT119
Identity
- Trade Name
- ONE MEDICAL EUDAMED
- Device Name
- Non-contact Infrared Thermometer EUDAMEDDigital Thermometer EUDAMED
- Model / Reference
- JXB-178, JXB-182, JXB-183, JXB-311, JXB-315, JXB-319, BL-6001, JXB-180, JXB-195, JXB-190, JXB-192, JA001, JXB-301, JXB-302, JXB-182B, JXB-308, JXB-320, LMP001, EW-TA50, EW-TA51 EUDAMEDJXB308+5AC041 EUDAMEDDT007, DT008, DT113, DT116, DT117, DT119 EUDAMED0DT008+1AC003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770030378062 EUDAMED03770030378055 EUDAMED
- Basic UDI-DI
- 69476561JXB-XXX7T EUDAMED69476561DTXXX4R EUDAMED
- Direct Marketing DI
- 03770030378062 EUDAMED03770030378055 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMEDV0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
One Medical by Guangzhou Berrcom Medical Device 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 | 69476561JXB-XXX7T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Berrcom Medical Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000013852
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED e74fe59d-55e5-4fdf-b0e2-7e5b068736e0 61 fields · synced Jul 31, 2026
- EUDAMED 14d29758-50e9-4c89-89cf-210b8661a70f 61 fields · synced May 19, 2026