510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Zhejiang Lanhine Medical Products Ltd.

Cixi City Zhejiang, CN

ZHEJIANG LANHINE MEDICAL PRODUCTS LTD. appears in FDA device records in Cixi City Zhejiang, 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 Zhejiang Lanhine Medical Products Ltd. in 2021.

Clearances by year, as a table
510(k) clearance decisions for Zhejiang Lanhine Medical Products Ltd., by decision year
YearClearances
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211827Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F)FXXSubstantially Equivalent
K211832Fluid Resistant Procedure Mask, Fluid Resistant Surgical MaskFXXSubstantially Equivalent

Registered establishments

FDA registered establishments for Zhejiang Lanhine Medical Products Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30166548903016654890ZHEJIANG LANHINE MEDICAL PRODUCTS LTD.No.99, 2nd Songpu Road, Binhai Economic Development Zone, Cixi City Zhejiang 315300 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

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