Promisemed Hangzhou Meditech Co., Ltd.
Manufacturer and brand owner in Hangzhou, Zhejiang, China. 21 device types, 11 products catalogued, 36 clearances.
Promisemed Hangzhou Meditech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Biopsy Needle, Injector, Pen and 19 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
21device types registered with the FDA
11products catalogued under its own name
36510(k) clearances
Registration
| Registered name | PROMISEMED HANGZHOU MEDITECH CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010515547 |
| FEI number | 3010515547 |
| DUNS | 421335278 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 普昂（杭州）医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91330110060952927C |
| Source | NMPA UDI database |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | No. 1388 Cangxing Street, |
| Postal code | 311121 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biopsy Needle | Class 2 | 2021 | 3 | |
| Container, Sharps | Class 2 | Sensifine Sharps Container, Promisemed Sharps Container, Verifine Sharps Container, Safefine Sharps Container, YDSDUTE Sharps Container | 2021 | 18 |
| Endoscopic Injection Needle, Gastroenterology-Urology | Class 2 | VeriEndo Endoscopic Injection Needles | 2026 | 23 |
| Forceps, Biopsy, Non-Electric | Class 1 | VeriEndo Single Use Biopsy Forceps | 2023 | 44 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | ReliOn Sterile Gauze Pads, Verifine Sterile Gauze Pads | 2026 | 266 |
| Hemostatic Metal Clip For The Gi Tract | Class 2 | VeriEndo Single Use Hemoclips | 2026 | 17 |
| Injector, Pen | Class 2 | 2019 | 2 | |
| Instrument, Biopsy | Class 2 | 2021 | 9 | |
| Insulin Vial Protector/Holder | Class 1 | Sensifine Cooler Travel Case, Verifine Cooler Travel Case | 2024 | 7 |
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | Sol-M Lancing Device | 2023 | 21 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Verifine blunt needle | 2023 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Promisemed X-Safety Pen Needle, Sensifine Pen Tips, Quinsen Pen Tips, Verifine Plus Pen Needles, TonmiCare Pen Needles, Verifine Insulin Pen Needles and 12 more | 2016 | 71 |
| Non-Coring (Huber) Needle | Class 2 | Promisemed Safety Huber Needle, Medline Huber Needle with Safety Click Advantage, JetCan Safety Huber Needles | 2023 | 4 |
| Set, Administration, Intravascular | Class 2 | 2021 | 49 | |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | VeriFine Safety Lancet, Verifine Blood Lancets, Sensifine Blood Lancets, Sensifine Safety Lancet, Verifine Lancing Device, Sensifine Lancing Device | 2016 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | VeriFine Safety Lancet, Verifine Blood Lancets, Sensifine Blood Lancets, Sensifine Safety Lancet | 2022 | 21 |
| Syringe, Antistick | Class 2 | ONE-CARE OPTI TB Safety Syringes, VeriSafe Safety Sterile Syringes, Verifine Safety Retractable Insulin Syringes | 2022 | 39 |
| Syringe, Irrigating (Non Dental) | Class 1 | Catheter tip syringe, Enfit oral syringe | 2023 | 110 |
| Syringe, Piston | Class 2 | ONE-CARE OPTI TB Safety Syringes, Sensifine Syringes, Esamita Insulin Syringe, Moiscckel 1ml/cc Disposable Syringe with 30Ga 1/2″ (12mm) Needle, Easy Glide Insulin Syringe, TonmiCare Syringes and 12 more | 2021 | 60 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | 2023 | 31 | |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Hartman Medical Group Blood Transfer Device | 2022 | 23 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Diathrive Health Insulin Pen Needle | FMI | 6 |
| CareTouch | FMI | 6 |
| Verifine | FMI | 3 |
| TonmiCare Pen Needles | FMI | 3 |
| Microdot | FMK | 2 |
| Verifine | MMK | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K261719 | 2026-08-25 | FMI | Special | This company |
| K261196 | 2026-05-12 | KNW | Special | This company |
| K261045 | 2026-05-01 | FMK | Special | This company |
| K254273 | 2026-04-16 | FMI | Special | This company |
| K250192 | 2025-12-10 | FMF | Traditional | This company |
| K250961 | 2025-06-04 | JKA | Traditional | This company |
| K251138 | 2025-05-13 | PTI | Special | This company |
| K243332 | 2025-03-14 | PTI | Special | This company |
| K243806 | 2025-01-10 | FMI | Special | This company |
| K240675 | 2024-10-04 | FBK | Traditional | This company |
| K242632 | 2024-09-26 | FMI | Special | This company |
| K234124 | 2024-07-12 | PKL | Traditional | This company |
| K231792 | 2023-09-28 | FMF | Traditional | This company |
| K230715 | 2023-06-08 | PTI | Traditional | This company |
| K223453 | 2023-03-02 | FMF | Traditional | This company |
| K223643 | 2023-02-21 | QRL | Traditional | This company |
| K222271 | 2023-02-15 | FMI | Traditional | This company |
| K220129 | 2022-09-19 | FMI | Traditional | This company |
| K221368 | 2022-06-09 | FMK | Special | This company |
| K221371 | 2022-06-08 | FMK | Special | This company |
| K213683 | 2022-04-22 | KNW | Traditional | This company |
| K213560 | 2022-04-05 | FMF | Traditional | This company |
| K211890 | 2021-11-17 | MMK | Traditional | This company |
| K211242 | 2021-09-09 | FMF | Traditional | This company |
| K210712 | 2021-09-08 | FMF | Traditional | This company |
| K210946 | 2021-08-12 | KNW | Traditional | This company |
| K210059 | 2021-07-21 | FMI | Traditional | This company |
| K211293 | 2021-06-25 | FMI | Traditional | This company |
| K210065 | 2021-04-22 | FMI | Traditional | This company |
| K193273 | 2021-01-05 | FMF | Traditional | This company |
| K202681 | 2020-12-31 | FMI | Special | This company |
| K202682 | 2020-11-24 | FMI | Special | This company |
| K193009 | 2019-12-03 | FMK | Traditional | This company |
| K192666 | 2019-12-02 | FMK | Traditional | This company |
| K191853 | 2019-09-05 | FMI | Traditional | This company |
| K161950 | 2017-05-11 | FMI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Main products | Insulin pen needles, Blood lancets, Safety lancets, Biopsy needles, Endoscopic forceps |
| Certifications | ISO, CE, FDA, MDSAP |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.