510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Hebei Zhemai Technology Co.,Ltd

Sanhe Hebei, CN

HEBEI ZHEMAI TECHNOLOGY CO.,LTD appears in FDA device records in Sanhe Hebei, CN. FDA records list 3 510(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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Hebei Zhemai Technology Co.,Ltd in 2023.

Clearances by year, as a table
510(k) clearance decisions for Hebei Zhemai Technology Co.,Ltd, by decision year
YearClearances
20233
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232708Intense pulsed light therapy deviceONFSubstantially Equivalent
K232716Q-Switched Nd:Yag laserGEXSubstantially Equivalent
K232709Diode laser therapy deviceGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Hebei Zhemai Technology Co.,Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30321478073032147807HEBEI ZHEMAI TECHNOLOGY CO.,LTDOn the second floor of Building 14 #1-101,Phase l, Zhongnan High tech,Yanjiao Science and Technology, Sanhe Hebei 065201 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

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