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Biosynex

EUDAMED

Class IIa (EU MDR)

Ref 859048Model 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

by Guangzhou Berrcom Medical Device Co., Ltd.

Identity

Trade Name
Biosynex 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 EUDAMED
859048 EUDAMED

Identifiers

Primary DI / UDI-DI
06947656117079 EUDAMED
06947656118847 EUDAMED
Basic UDI-DI
69476561JXB-XXX7T EUDAMED
Direct Marketing DI
06947656117079 EUDAMED
06947656118847 EUDAMED
EMDN Code
V0301010202 NON-CONTACT DIGITAL THERMOMETERS 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

Biosynex 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

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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 5d4dcd20-f355-4f2c-8b6e-40ad6d1cb9db 61 fields · synced Aug 5, 2026
  • EUDAMED 795e7fc3-57e8-4687-a0af-e0cce878070c 61 fields · synced Aug 5, 2026