Chrysalis Intelligence · Sponsors · Promisemed Hangzhou Meditech Co., Ltd.

Promisemed Hangzhou Meditech Co., Ltd.

Hangzhou City, CN · 31 510(k) clearances

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
31
2020-11-24 → 2026-05-12
Last 12 months
4
Product codes
10
Most recent
2026-05-12
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FMI Needle, Hypodermic, Single Lumen Class II General Hospital 10 2026-04-16
FMF — — — 7 2025-12-10
KNW Instrument, Biopsy Class II Gastroenterology, Urology 3 2026-05-12
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature Class II General, Plastic Surgery 3 2026-05-01
PTI Non-Coring (Huber) Needle Class II General Hospital 3 2025-05-13
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Class II Clinical Chemistry 1 2025-06-04
FBK Endoscopic Injection Needle, Gastroenterology-Urology Class II Gastroenterology, Urology 1 2024-10-04
PKL Hemostatic Metal Clip For The Gi Tract Class II Gastroenterology, Urology 1 2024-07-12
QRL — — — 1 2023-02-21
MMK Container, Sharps Class II General Hospital 1 2021-11-17
Filings

All 510(k) clearances (31)

Date K-number Device Code Class Specialty
2026-05-12 K261196 Promisemed VeriEcto Automatic Biopsy Needles KNW Class II Gastroenterology, Urology
2026-05-01 K261045 Verifine Safety Lancets FMK Class II General, Plastic Surgery
2026-04-16 K254273 Verisafe Safety Sterile Needles (SSN) FMI Class II General Hospital
2025-12-10 K250192 Verisafe Safety Retractable Insulin Syringes FMF — —
2025-06-04 K250961 Blood collection tube holders JKA Class II Clinical Chemistry
2025-05-13 K251138 Promisemed Safety Huber Needles PTI Class II General Hospital
2025-03-14 K243332 Promisemed Safety Huber Needles PTI Class II General Hospital
2025-01-10 K243806 Safety Winged Blood Collection Sets FMI Class II General Hospital
2024-10-04 K240675 Endoscopic Injection Needles FBK Class II Gastroenterology, Urology
2024-09-26 K242632 Verifine® Pen Needles FMI Class II General Hospital
2024-07-12 K234124 Single Use Hemoclips PKL Class II Gastroenterology, Urology
2023-09-28 K231792 VeriSafe Safety sterile syringes FMF — —
2023-06-08 K230715 Promisemed Safety Huber Needle PTI Class II General Hospital
2023-03-02 K223453 Insulin Syringe FMF — —
2023-02-21 K223643 Verifine® Ease Lancing Device, Verifine® Lancing Device QRL — —
2023-02-15 K222271 Verisafe Safety sterile needles FMI Class II General Hospital
2022-09-19 K220129 Promisemed X-Safety Pen Needle FMI Class II General Hospital
2022-06-09 K221368 Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet FMK Class II General, Plastic Surgery
2022-06-08 K221371 Promisemed Heel Blood Lancet FMK Class II General, Plastic Surgery
2022-04-22 K213683 Promisemed Fine Biopsy Needle KNW Class II Gastroenterology, Urology
2022-04-05 K213560 Verifine Safety Syringe with Fixed Needle FMF — —
2021-11-17 K211890 Promisemed Sharps container MMK Class II General Hospital
2021-09-09 K211242 Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes FMF — —
2021-09-08 K210712 Verifine Mechanical Safety Insulin Syringe FMF — —
2021-08-12 K210946 Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles KNW Class II Gastroenterology, Urology
2021-07-21 K210059 Promisemed Insulin Pen Needle FMI Class II General Hospital
2021-06-25 K211293 Safety Winged Blood Collection Sets FMI Class II General Hospital
2021-04-22 K210065 Verifine Safety Type Insulin Pen Needle FMI Class II General Hospital
2021-01-05 K193273 Insulin Syringe FMF — —
2020-12-31 K202681 Promisemed Covered Safety Pen Needle FMI Class II General Hospital
2020-11-24 K202682 Promisemed Triple Safety Pen Needle FMI Class II General Hospital
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence