Data / Medical devices / China / Promisemed Hangzhou Meditech Co.,ltd.

Promisemed Hangzhou Meditech Co.,ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 32 510(k) clearances

Name: Promisemed Hangzhou Meditech Co.,ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Promisemed Hangzhou Meditech Co.,ltd. is registered with the FDA (registration 3010515547) in Hangzhou Zhejiang, China. It lists 21 device types. The FDA files 32 510(k) clearances under its listings, the newest dated April 16, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010515547
Address: No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou Zhejiang, China, 311121
Owner or operator: Promisemed Hangzhou Meditech Co.,Ltd. (10045479)
Roles: Contract manufacturer, Exporter to the US, Manufacturer
First device listed: November 2, 2016
Registered through: 2026
Brand names listed: Advocate Insulin Pen Needles, Catheter tip syringe, DolpBay Insulin Syringe, Dolpbay Insulin Syringe, Easy Glide Insulin Syringe, Enfit oral syringe, Esamita Insulin Syringe, GLUCO-CARE Insulin Syringe and more

Devices it lists

Device	Product code	Class	Role	Source
Biopsy Needle	FCG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Container, Sharps	MMK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Injector, Pen	NSC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Instrument, Biopsy	KNW	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Insulin Vial Protector/Holder	OJL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer	accessdata.fda.gov
Needle, Hypodermic, Single Lumen	FMI	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Non-Coring (Huber) Needle	PTI	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Antistick	MEG	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
System, Blood Collection, Vacuum-Assisted, Manual	KST	1	Manufacturer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 16, 2026	K254273	Verisafe Safety Sterile Needles (SSN)	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
December 10, 2025	K250192	Verisafe Safety Retractable Insulin Syringes	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
June 4, 2025	K250961	Blood collection tube holders	JKA	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
May 13, 2025	K251138	Promisemed Safety Huber Needles	PTI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
January 10, 2025	K243806	Safety Winged Blood Collection Sets	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
October 4, 2024	K240675	Endoscopic Injection Needles	FBK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 26, 2024	K242632	Verifine® Pen Needles	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
July 12, 2024	K234124	Single Use Hemoclips	PKL	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 28, 2023	K231792	VeriSafe Safety sterile syringes	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
June 8, 2023	K230715	Promisemed Safety Huber Needle	PTI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
March 2, 2023	K223453	Insulin Syringe	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
February 21, 2023	K223643	Verifine® Ease Lancing Device, Verifine® Lancing Device	QRL	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
February 15, 2023	K222271	Verisafe Safety sterile needles	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 19, 2022	K220129	Promisemed X-Safety Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
June 9, 2022	K221368	Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet	FMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
June 8, 2022	K221371	Promisemed Heel Blood Lancet	FMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
April 22, 2022	K213683	Promisemed Fine Biopsy Needle	KNW	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
April 5, 2022	K213560	Verifine Safety Syringe with Fixed Needle	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
November 17, 2021	K211890	Promisemed Sharps container	MMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 9, 2021	K211242	Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 8, 2021	K210712	Verifine Mechanical Safety Insulin Syringe	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
August 12, 2021	K210946	Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles	KNW	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
July 21, 2021	K210059	Promisemed Insulin Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
June 25, 2021	K211293	Safety Winged Blood Collection Sets	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
April 22, 2021	K210065	Verifine Safety Type Insulin Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
January 5, 2021	K193273	Insulin Syringe	FMF	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
December 31, 2020	K202681	Promisemed Covered Safety Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
November 24, 2020	K202682	Promisemed Triple Safety Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
December 3, 2019	K193009	Promisemed Heel Blood Lancet	FMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
December 2, 2019	K192666	Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet	FMK	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
September 5, 2019	K191853	Dual-Safety Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov
May 11, 2017	K161950	Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle	FMI	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated April 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.