Zhejiang Baite Medical Appliances Co., Ltd.
Registered establishment in Huzhou, Zhejiang, China. 13 device types.
Zhejiang Baite Medical Appliances Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Bag, Reservoir and 11 other device types. Its earliest product listing with the FDA dates from 2003.
Registration
| Registered name | ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3004134948 |
| FEI number | 3004134948 |
| Establishment type | Contract manufacturer, Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 浙江百特医疗用品有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Huzhou |
|---|---|
| Province | Zhejiang |
| Address | 18 Xinlian Street, Xinshi Town, Deqing County |
| Postal code | 313201 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | EYE Shield, NON Surgical Face Mask, Face Shield, Protection Shield, NON Surgical Particle Respirator, NON Surgical Medical Mask and 1 more | 2020 | 439 |
| Bag, Reservoir | Class 1 | Multiple (Aerosol Drainage System) | 2006 | 28 |
| Cannula, Nasal, Oxygen | Class 1 | Multiple (Nasal Oxygen Cannula, Oxygen Cannula) | 2006 | 97 |
| Catheter, Irrigation | Class 1 | Infiltration Tubing | 2025 | 24 |
| Catheters, Suction, Tracheobronchial | Class 1 | Suction Catheter, Coiled | 2003 | 93 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | Humidifier | 2020 | 55 |
| Mask, Oxygen | Class 1 | Oxygen Mask(With Optional Oxygen Tube, Nebulizer,air BAG, Chamber OR Valves) | 2007 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Mask with 6 Diluter Jets | 2019 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | Non-Rebreathing Mask with 2M Tube | 2019 | 72 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Nebulizer/Nebulizer KIT/Nebulizers | 2007 | 57 |
| Set, Tubing And Support, Ventilator (W Harness) | Class 1 | Corrugated Tubing | 2003 | 33 |
| Tracheobronchial Suction Catheter Kit | Class 1 | Suction Catheter Kit | 2024 | 9 |
| Vinyl Patient Examination Glove | Class 1 | Powder -Free Patient Examination Gloves | 2024 | 72 |
Clearances
No clearance names Zhejiang Baite Medical Appliances Co., Ltd. as applicant. One is 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 |
|---|---|---|---|---|
| K101565 | 2010-08-17 | LYZ | Traditional | Zibio Yingjie Medical Products Co., Ltd. |
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.