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Forehead Thermometer

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref AOJ-F101Model AOJ-F101, AOJ-F102, AOJ-F103510(k) K221170

by Shenzhen AOJ Medical Technology Co., Ltd.

Identity

Trade Name
Forehead Thermometer EUDAMED
Device Name
Forehead Thermometer EUDAMED
Model / Reference
AOJ-F101, AOJ-F102, AOJ-F103 EUDAMED
AOJ-F101 EUDAMED

Identifiers

Primary DI / UDI-DI
06972040112071 EUDAMED
Basic UDI-DI
697204011F10X84 EUDAMED
Direct Marketing DI
06972040112071 EUDAMED
510(k) Number
K221170 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

Forehead Thermometer by Shenzhen AOJ Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shenzhen AOJ Medical Technology Co., Ltd.
EUDAMED SRN
CN-MF-000018386
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (2)

  • EUDAMED 9fdd31ac-a1c3-4112-8b0c-5c3d9194ce5a 61 fields · synced Oct 6, 2026
  • FDA 510(k) K221170 24 fields · synced May 18, 2026