← Back to catalogue
Berrcom
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref JXB195+5AR042Model 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
- Berrcom EUDAMEDFDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- 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 EUDAMEDJXB195+5AR042 EUDAMEDJXB-195 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06947656112838 EUDAMEDFDA UDI
- Basic UDI-DI
- 69476561JXB-XXX7T EUDAMED
- Direct Marketing DI
- 06947656112838 EUDAMED
- FDA Product Code
- SDV FDA UDIFLL FDA UDI
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
- GMDN Term
- Infrared patient thermometer, skin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Berrcom by Guangzhou Berrcom Medical Device Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69476561JXB-XXX7T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 6396e3c2-3263-44f9-8f35-7c3ee5e20afe 61 fields · synced May 30, 2026
- FDA UDI ae0d4d2e-3d66-466b-9cdb-eff740841c52 32 fields · synced May 30, 2026