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

Taichung City, TW

HSINER CO., LTD. appears in FDA device records in Taichung City, TW. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. 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
9
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 9 510(k) clearances for Hsiner Co., Ltd. between 2005 and 2026. The busiest year on record is 2007, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Hsiner Co., Ltd., by decision year
YearClearances
20051
20061
20072
20081
20091
20111
20121
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251888VPAP Pediatric Face MaskCBKSubstantially Equivalent
K120920HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULABZDSubstantially Equivalent
K102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202CBKSubstantially Equivalent
K09118570530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTERCAHSubstantially Equivalent
K082009HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDSCAFSubstantially Equivalent
K070948HSINER NEBULIZER BOTTLECAFSubstantially Equivalent
K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZDSubstantially Equivalent
K053466HSINER RESUSCITATORBTMSubstantially Equivalent
K052811HSINER JET NEBULIZER, MODEL HS-31100CAFSubstantially Equivalent

Registered establishments

FDA registered establishments for Hsiner Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30038621883003862188HSINER CO., LTD.312, Jhongshang Rd., Shengang Dist., TAICHUNG CITY 429 TW2026and 16 more, listed in full below
30313696513031369651HSINER CO., LTD.No. 251, Sec.1,Houke Rd., Houli Dist., Taichung City 421 TW2026and 16 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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Data as of , FDA export datePage updated Source: openFDA, public domain