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

Taipei City, TW

HJY SMART MEDICAL DEVICE CO., LTD. appears in FDA device records in Taipei City, TW. FDA records list 2 510(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
2
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Hjy Smart Medical Device Co., Ltd. between 2023 and 2025. The busiest year on record is 2023, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hjy Smart Medical Device Co., Ltd., by decision year
YearClearances
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243429HJY VisualNext 3D Endoscopic Vision SystemGWGSubstantially Equivalent
K222735HJY VisualNext Endoscopic Vision SystemGWGSubstantially Equivalent

Registered establishments

FDA registered establishments for Hjy Smart Medical Device Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30253414493025341449HJY SMART MEDICAL DEVICE CO., LTD.12F, No. 415, Sec. 4, Xinyi Rd., Xinyi Dist., Taipei City 11051 TW2026

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