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Shanghai Hua en Industrial Co Ltd

Shanghai, CN

Shanghai Hua En Industrial Co Ltd appears in FDA device records in Shanghai, 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 Shanghai Hua en Industrial Co Ltd in 2022.

Clearances by year, as a table
510(k) clearance decisions for Shanghai Hua en Industrial Co Ltd, by decision year
YearClearances
20222
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K221838Surgical Face Mask (HNFM0103)FXXSubstantially Equivalent
K221222Surgical Face Mask (HNFM0304)FXXSubstantially Equivalent

Registered establishments

FDA registered establishments for Shanghai Hua en Industrial Co Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30101472743010147274Shanghai Hua En Industrial Co Ltd#30, NO988 HUI JI ROAD, XUANQIAO, Shanghai 201314 CN2026and 42 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

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