Zhejiang Haisheng Medical Device Co., Ltd.
Manufacturer and brand owner in Shaoxing, Zhejiang, China. 21 device types, 3 products catalogued, 2 clearances.
Zhejiang Haisheng Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Oxygen, Bag, Reservoir and 19 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
Registration
| Registered name | ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008693658 |
| FEI number | 3008693658 |
| DUNS | 527974856 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 浙江海圣医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91330600724537794K |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | No.8, ZhenYuan Road |
| Postal code | 312071 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorbent, Carbon-Dioxide | Class 1 | 2010 | 4 | |
| Adaptor, Holder, Syringe | Class 1 | Transducer holder | 2024 | 15 |
| Airway, Nasopharyngeal | Class 1 | Disposable Nasopharyngeal airway | 2012 | 52 |
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Disposable Oropharyngeal Airway, Disposable Laryngeal Mask Airway | 2012 | 84 |
| Anesthesia Breathing Circuit Kit (Adult & Pediatric) | Class 1 | Disposable Anesthesia breathing circuit | 2023 | 11 |
| Bag, Reservoir | Class 1 | Anaesthetic reservoir bag | 2013 | 28 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal oxygen cannula | 2023 | 97 |
| Catheter And Tip, Suction | Class 2 | Disposable Closed Suction Catheter, Disposable Oral Care Suction Catheter | 2006 | 70 |
| Catheters, Suction, Tracheobronchial | Class 1 | Disposable Oral Care Suction Catheter, Disposable Closed Suction Catheter | 2006 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Disposable Anesthesia Breathing Circuit, Gas sampling line | 2010 | 55 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Tracheotomy Filter | 2019 | 29 |
| Connector, Airway (Extension) | Class 1 | catheter mount, Bubble Tubing | 2025 | 20 |
| Device, Fixation, Tracheal Tube | Class 1 | Disposable Fixing Set for Tracheal Cannula | 2012 | 46 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | Disposable Anesthesia Breathing Circuit | 2013 | 15 |
| Laryngoscope, Rigid | Class 1 | disposable laryngoscope blade | 2005 | 44 |
| Mask, Gas, Anesthetic | Class 1 | Anesthesia Mask | 2017 | 71 |
| Mask, Oxygen | Class 1 | Oxygen mask | 2015 | 126 |
| Staple, Removable (Skin) | Class 1 | Disposable Skin Staple Remover | 2012 | 20 |
| Syringe, Irrigating (Non Dental) | Class 1 | Syringe | 2005 | 110 |
| Transducer, Blood-Pressure, Extravascular | Class 2 | 2016 | 7 | |
| Tubing, Pressure And Accessories | Class 1 | Gas Sampling Line | 2013 | 45 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Disposable Bacterial/Viral Filter | CAH | 2 |
| Cables AND Sensors Disposable Pressure Transducer | DRS | 2 |
| Disposable Blood Pressure Transducer | DRS | 1 |
Clearances
2 clearances name Zhejiang Haisheng Medical Device Co., Ltd. as applicant. 1 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 |
|---|---|---|---|---|
| K152472 | 2016-10-31 | DRS | Traditional | This company |
| K151498 | 2015-12-18 | CAH | Traditional | This company |
| K033008 | 2004-05-13 | CAH | Traditional | Air Safety, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Factory area | 66,000 sq m |
| Main products | Anesthesia devices, Video laryngoscope, Breathing circuits, Breathing filters, Monitoring equipment |
| Certifications | FDA 510(K), CE, Medical device registrations (53), Patent certificates (63) |
| Export markets | Global markets |
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.