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Shenzhen Rogin Medical Co., Ltd

shenzhen Guangdong, CN

SHENZHEN ROGIN MEDICAL 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 Shenzhen Rogin Medical Co., Ltd in 2025.

Clearances by year, as a table
510(k) clearance decisions for Shenzhen Rogin Medical Co., Ltd, by decision year
YearClearances
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)EKXSubstantially Equivalent
K242383Apex LocatorLQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Shenzhen Rogin Medical Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30151369273015136927SHENZHEN ROGIN MEDICAL CO., LTDRm 3109, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist, shenzhen Guangdong 518129 CN2026and 41 more, listed in full below

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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What MDM checks, and what it does not

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