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Alicn Medical Shenzhen, Inc

Shenzhen Guangdong, CN

ALICN MEDICAL SHENZHEN, INC appears in FDA device records in Shenzhen Guangdong, CN. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
13
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 13 510(k) clearances for Alicn Medical Shenzhen, Inc between 2018 and 2023. The busiest year on record is 2022, with 6. The most recent is 2023, with 4.

Clearances by year, as a table
510(k) clearance decisions for Alicn Medical Shenzhen, Inc, by decision year
YearClearances
20181
20191
20211
20226
20234
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232338Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383FLLSubstantially Equivalent
K231050Arm Blood Pressure MonitorDXNSubstantially Equivalent
K230649Arm Blood Pressure MonitorDXNSubstantially Equivalent
K222248Infrared ThermometerFLLSubstantially Equivalent
K221913Arm Blood Pressure MonitorDXNSubstantially Equivalent
K210937Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241FLLSubstantially Equivalent
K210565Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711FLLSubstantially Equivalent
K212257Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311FLLSubstantially Equivalent
K212877Arm Blood Pressure MonitorDXNSubstantially Equivalent
K210564Infrared ThermometerFLLSubstantially Equivalent
K210563Arm Blood Pressure MonitorDXNSubstantially Equivalent
K180435Arm Blood Pressure MonitorDXNSubstantially Equivalent
K180207Non-contact Infrared ThermometerFLLSubstantially Equivalent

Registered establishments

FDA registered establishments for Alicn Medical Shenzhen, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30098894713009889471ALICN MEDICAL SHENZHEN, INCRoom 301, Building D, Chaojie Industrial Park, No. 1 Guanghui Road, Shenzhen Guangdong 518122 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain