Wellmien Healthcare Tech.(Suzhou) Co., Ltd.
Registered establishment in Suzhou, Jiangsu, China. 22 device types.
Wellmien Healthcare Tech.(Suzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Eye, Cap, Surgical and 20 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | WELLMIEN HEALTHCARE TECH.(SUZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014819517 |
| FEI number | 3014819517 |
| Establishment type | Contract manufacturer, Specification developer, Manufacturer, Exporter |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | 1-3603, Global 188, NO.88 Suhui Road, Suzhou Industrial Park |
| Postal code | 215000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Oversleeves | 2021 | 439 |
| Apron, Protective | Class 1 | Apron | 2021 | 46 |
| Bedding, Disposable, Medical | Class 1 | Medical Bedding and Blanket, Disposable pillow, Reusable pillow, Non-woven pillow, Disposable Bed pillow, Disposable hygienic pillows | 2021 | 308 |
| Cap, Surgical | Class 1 | Surgical Cap | 2021 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Shoe Cover | 2021 | 176 |
| Disinfectant, Medical Devices | Class 1 | Pad, Alcohol, Device Disinfectant | 2021 | 197 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2021 | 182 |
| Fiber, Medical, Absorbent | Class 1 | OR Towel, Operation Towel, Surgical operation towel(without x-ray detectable), absorbent pads, Non woven swab/Non woven pad (without x-ray detectable), Non woven ball(without x-ray detectable) | 2021 | 172 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze / sponge | 2021 | 266 |
| Gown, Examination | Class 1 | Examination Gowns | 2021 | 109 |
| Mask, Surgical | Class 2 | Surgical Mask | 2021 | 125 |
| Medical Glove, Specialty | Class 1 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | 2023 | 48 |
| Needle, Hypodermic, Single Lumen | Class 2 | Syringe with Needle | 2021 | 71 |
| Non-Surgical Gown | Class 1 | CPE Gowns | 2021 | 318 |
| Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68) | Class 1 | Nursing Pad | 2021 | 48 |
| Pad, Eye | Class 1 | Eye Pad | 2021 | 100 |
| Polymer Patient Examination Glove | Class 1 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs, Nitrile Powder Free Patient Examination Gloves, Blue Color | 2023 | 83 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Goggles, safety goggles, eye shield | 2021 | 384 |
| Shield, Protective, Personnel | Class 1 | Face Shield | 2021 | 78 |
| Syringe, Antistick | Class 2 | Syringe with Needle | 2021 | 39 |
| Syringe, Piston | Class 2 | Syringe with Needle | 2021 | 60 |
| Tape And Bandage, Adhesive | Class 1 | Tape and bandage, adhesive | 2021 | 353 |
Clearances
No clearance names Wellmien Healthcare Tech.(Suzhou) Co., Ltd. as applicant. 4 are held by other companies 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 |
|---|---|---|---|---|
| K183665 | 2019-09-06 | MEG | Traditional | Jiangsu Micsafe Medical Technology Co., Ltd. |
| K171873 | 2017-11-15 | LZA | Traditional | Zhonghong Pulin Medical Products Co., Ltd. |
| K152712 | 2016-03-09 | LZA | Traditional | Zhonghong Pulin Medical Products Co., Ltd. |
| K101000 | 2010-08-09 | FXX | Abbreviated | Wellmien (Suzhou) Import & Export Trading Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Factory area | 8000 m² |
| Main products | Surgical face masks, Isolation gowns, Disposable gloves, Surgical dressings, Disposable bed sheets |
| Certifications | ISO 13485:2016, CE |
| Export markets | Global distribution network |
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.