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Thermo Der
EUDAMEDClass IIa (EU MDR)
Ref JXB183+8BC040Model 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
Identity
- Trade Name
- THERMO DER EUDAMED
- Device Name
- Non-contact Infrared 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 EUDAMEDJXB183+8BC040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437002731045 EUDAMED
- Basic UDI-DI
- 69476561JXB-XXX7T EUDAMED
- Direct Marketing DI
- 08437002731045 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Thermo Der 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 (1)
- EUDAMED e28674ab-16c4-4990-a6a6-3139fddcb401 61 fields · synced Jun 18, 2026