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

Hangzhou Zhejiang, CN

PROMISEMED HANGZHOU MEDITECH CO.,LTD. appears in FDA device records in Hangzhou Zhejiang, CN. FDA records list 35 510(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
35
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 35 510(k) clearances for Promisemed Hangzhou Meditech Co.,Ltd. between 2017 and 2026. The busiest year on record is 2021, with 8. The most recent is 2026, with 3.

Clearances by year, as a table
510(k) clearance decisions for Promisemed Hangzhou Meditech Co.,Ltd., by decision year
YearClearances
20171
20193
20202
20218
20225
20235
20243
20255
20263
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261196Promisemed VeriEcto Automatic Biopsy NeedlesKNWSubstantially Equivalent
K261045Verifine Safety LancetsFMKSubstantially Equivalent
K254273Verisafe Safety Sterile Needles (SSN)FMISubstantially Equivalent
K250192Verisafe Safety Retractable Insulin SyringesFMFSubstantially Equivalent
K250961Blood collection tube holdersJKASubstantially Equivalent
K251138Promisemed Safety Huber NeedlesPTISubstantially Equivalent
K243332Promisemed Safety Huber NeedlesPTISubstantially Equivalent
K243806Safety Winged Blood Collection SetsFMISubstantially Equivalent
K240675Endoscopic Injection NeedlesFBKSubstantially Equivalent
K242632Verifine® Pen NeedlesFMISubstantially Equivalent
K234124Single Use HemoclipsPKLSubstantially Equivalent
K231792VeriSafe Safety sterile syringesFMFSubstantially Equivalent
K230715Promisemed Safety Huber NeedlePTISubstantially Equivalent
K223453Insulin SyringeFMFSubstantially Equivalent
K223643Verifine® Ease Lancing Device, Verifine® Lancing DeviceQRLSubstantially Equivalent
K222271Verisafe Safety sterile needlesFMISubstantially Equivalent
K220129Promisemed X-Safety Pen NeedleFMISubstantially Equivalent
K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMKSubstantially Equivalent
K221371Promisemed Heel Blood LancetFMKSubstantially Equivalent
K213683Promisemed Fine Biopsy NeedleKNWSubstantially Equivalent
K213560Verifine Safety Syringe with Fixed NeedleFMFSubstantially Equivalent
K211890Promisemed Sharps containerMMKSubstantially Equivalent
K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesFMFSubstantially Equivalent
K210712Verifine Mechanical Safety Insulin SyringeFMFSubstantially Equivalent
K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy NeedlesKNWSubstantially Equivalent
K210059Promisemed Insulin Pen NeedleFMISubstantially Equivalent
K211293Safety Winged Blood Collection SetsFMISubstantially Equivalent
K210065Verifine Safety Type Insulin Pen NeedleFMISubstantially Equivalent
K193273Insulin SyringeFMFSubstantially Equivalent
K202681Promisemed Covered Safety Pen NeedleFMISubstantially Equivalent
K202682Promisemed Triple Safety Pen NeedleFMISubstantially Equivalent
K193009Promisemed Heel Blood LancetFMKSubstantially Equivalent
K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMKSubstantially Equivalent
K191853Dual-Safety Pen NeedleFMISubstantially Equivalent
K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMISubstantially Equivalent

Registered establishments

FDA registered establishments for Promisemed Hangzhou Meditech Co.,Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30105155473010515547PROMISEMED HANGZHOU MEDITECH CO.,LTD.No. 1388 Cangxing Street,, Hangzhou Zhejiang 311121 CN2026and 11 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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Data as of , FDA export datePage updated Source: openFDA, public domain