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Alvita
EUDAMEDClass IIa (EU MDR)
Ref JXB319+5AC050Model 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 JXB319+GAC051 Ref JXB319+GAC052
Identity
- Trade Name
- Alvita 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 EUDAMEDJXB319+5AC050 EUDAMEDJXB319+GAC051 EUDAMEDJXB319+GAC052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947656116898 EUDAMED05055382309284 EUDAMED05055382309819 EUDAMED
- Basic UDI-DI
- 69476561JXB-XXX7T EUDAMED
- Direct Marketing DI
- 06947656116898 EUDAMED05055382309284 EUDAMED05055382309819 EUDAMED
- EMDN Code
- V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain EUDAMEDRomania 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
Alvita 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 (3)
- EUDAMED 874a50fa-b68f-4e09-a298-cdc451693078 61 fields · synced Jul 27, 2026
- EUDAMED d081a888-14a3-434f-96ce-b380a7630f98 61 fields · synced May 17, 2026
- EUDAMED 554b8764-63e0-405b-93d5-d6ff9f63f995 61 fields · synced May 17, 2026