Top-Rank Health Care Co., Ltd.
Manufacturer and brand owner in Shaoxing, Zhejiang, China. 7 device types, 11 products catalogued, 4 clearances.
Top-rank Health Care Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrode, Cutaneous and 5 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2007.
Registration
| Registered name | Top-rank Health Care Co.,Ltd. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006626283 |
| FEI number | 3006626283 |
| DUNS | 529504164 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 浙江荣企医疗科技有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | Mashan Village, Dongguan Street |
| Postal code | 312352 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Electrode cable | 2010 | 47 |
| Device, Iontophoresis, Other Uses | Class 2 | Iontophoresis Electrodes ION-T02, Iontophoresis Electrodes ION-T04, Iontophoresis Electrodes ION-T01, Iontophoresis Electrodes ION-T03, Iontophoresis Electrodes ION-T05 | 2024 | 2 |
| Electrode, Cutaneous | Class 2 | Pre-Gelled Oval Electrode Pads, 3″x 5″, ET-5454, B074ZDVYYN, TC5050-TC, TC50100-TC, Pre-Gelled Square Electrode Pads, 2″ x 2″, Pre-Gelled Butterfly 3.5″ x 5″, ET-8484, B07K8YQ5C7, Reserv 2X4 Self-Adhering Electrodes, Easy@Home TENS/EMS Pulse Stimulator Replacement Pads and 47 more | 2007 | 47 |
| Electrode, Electrocardiograph | Class 2 | YF55N Diameter 55mm for adult, YB3448F 34mm 48 mm for adult, YE2834M 28mm 34 mm for pediatric, YE2334M 23mm 34 mm for pediatric, YD2444F 24mm 44 mm for adult, YC4345F 43mm 45 mm for adult and 14 more | 2016 | 33 |
| Electrosurgical Patient Return Electrode | Class 2 | EI04, EI02, EP04, EP03, EP01, EC04 and 2 more | 2024 | 2 |
| Media, Electroconductive | Class 2 | Jmoon Conductive Gel, TG01-40, Conductive Gel(Model: TG01-50;TG01-65;TG01-90;TG01-100;TG01-125;TG01-160;TG01-200;TG01-250;CG2252);TG-250ML; TG01-250, Medvat Conductive Gel: MED-USG-TR-CLEAR-22-2PK-A, TG01-15, TG01-70 | 2023 | 8 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Transcutaneous Electrical Nerve Stimulator, Electronic Pulse Stimulator-MDTS100 | 2021 | 57 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Lotfancy | GXY | 3 |
| reajoy | GXY | 2 |
| HQX | GXY | 2 |
| Medvat | GYB | 2 |
| reajoy | NUH | 1 |
| Pain Management | GXY | 1 |
| Health Mate Forever | GXY | 1 |
| FyneLook | GYB | 1 |
| Medlot | GXY | 1 |
| EZ MED Supplies | GXY | 1 |
| Belifu | GXY | 1 |
Clearances
4 clearances name Top-rank Health Care Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K232020 | 2023-10-16 | EGJ | Traditional | This company |
| K222770 | 2022-12-13 | GYB | Traditional | This company |
| K210223 | 2021-12-15 | NUH | Traditional | This company |
| K160366 | 2016-08-19 | ODR | Traditional | This company |
| K132588 | 2013-11-22 | GXY | Traditional | Top-Rank Health Care Equipment Co., Ltd. |
| K070612 | 2007-05-07 | GXY | Traditional | Top-Rank Health Care Equipment Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Employees | 200+ |
| Factory area | 13000 m² |
| Main products | Electrode pads, TENS/EMS units, Conductive gels, Defibrillator pads, Grounding pads |
| Certifications | MDSAP, ISO13485, ISO14001, FDA, CE, UKCA |
| Export markets | 30+ countries |
| OEM and ODM | Offered |
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.