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Infrared thermometer

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 92031001002Model YJ600510(k) K232473

by Zhuhai Yueja Medical Device Technology Co., Ltd.

Identity

Trade Name
Infrared thermometer EUDAMED
Device Name
Infrared thermometer EUDAMED
Model / Reference
YJ600 EUDAMED
92031001002 EUDAMED

Identifiers

Primary DI / UDI-DI
06975039337868 EUDAMED
Basic UDI-DI
697503933YJ600KN EUDAMED
Direct Marketing DI
06975039337868 EUDAMED
510(k) Number
K232473 FDA 510(k)
FDA Product Code
FLL FDA 510(k)
EMDN Code
V0301010202 NON-CONTACT DIGITAL THERMOMETERS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2910 FDA 510(k)
Regulation Number
880.2910 FDA 510(k)
Market of Registration
Germany EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Infrared thermometer by Zhuhai Yueja Medical Device Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Zhuhai Yueja Medical Device Technology Co., Ltd.
EUDAMED SRN
CN-MF-000026087
Authorised Representative
phoenix Medtech GmbH DE-AR-000007996

Sources (2)

  • EUDAMED c013cfb4-b5cb-4fbe-ba02-6b8325e5116b 61 fields · synced Jul 18, 2026
  • FDA 510(k) K232473 24 fields · synced May 18, 2026