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

Shenzhen Guangdong, CN

GMDASZ MANUFACTURING CO., LTD. appears in FDA device records in Shenzhen Guangdong, 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 Gmdasz Manufacturing Co., Ltd. between 2009 and 2016. The busiest year on record is 2009, with 1. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Gmdasz Manufacturing Co., Ltd., by decision year
YearClearances
20091
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K160138Adhesive ElectrodesGXYSubstantially Equivalent
K092546GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CMGXYSubstantially Equivalent

Registered establishments

FDA registered establishments for Gmdasz Manufacturing Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30081978843008197884GMDASZ MANUFACTURING CO., LTD.Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District, Shenzhen Guangdong 518052 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