510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dongguan ZSR Biomedical Technology Company Limited

Dongguan Guangdong, CN

DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED appears in FDA device records in Dongguan 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 Dongguan ZSR Biomedical Technology Company Limited between 2024 and 2025. The busiest year on record is 2024, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dongguan ZSR Biomedical Technology Company Limited, by decision year
YearClearances
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243155Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)FGBSubstantially Equivalent
K241181Disposable Ureteral Guide SheathFEDSubstantially Equivalent

Registered establishments

FDA registered establishments for Dongguan ZSR Biomedical Technology Company Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30166903373016690337DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITEDUnit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., Dongguan Guangdong 523651 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