Inko Medical

EUDAMED

Class IIa (EU MDR)

Ref JXB183+8AC05JModel 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: Inko Medical 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
JXB183+8AC05J EUDAMED

Identifiers

Primary DI / UDI-DI: 08436608913312 EUDAMED
Basic UDI-DI: 69476561JXB-XXX7T EUDAMED
Direct Marketing DI: 08436608913312 EUDAMED
EMDN Code: V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Inko 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 (1)

EUDAMED 8cc64e2e-b75f-4a5f-a89a-c3d8d65d316b 61 fields · synced Jul 10, 2026