510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Sino Medical Sciences Technology Inc.

Tianjin, CN

SINO MEDICAL SCIENCES TECHNOLOGY INC. appears in FDA device records in Tianjin, CN. 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 Sino Medical Sciences Technology Inc. between 2022 and 2023. The busiest year on record is 2022, with 1. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sino Medical Sciences Technology Inc., by decision year
YearClearances
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223022SC HONKYTONK PTCA Balloon Dilatation CatheterLOXSubstantially Equivalent
K222538NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation CatheterLOXSubstantially Equivalent

Registered establishments

FDA registered establishments for Sino Medical Sciences Technology Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30092051523009205152SINO MEDICAL SCIENCES TECHNOLOGY INC.TEDA Biopharm Res. Building B and 4th Floor Building A, #5 4th St. TEDA,, Tianjin 300457 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