Shaoxing Haitech Medical Products Co., Ltd.
Manufacturer and brand owner in Shaoxing, Zhejiang, China. 13 device types, 1 product catalogued, 1 clearance.
Shaoxing Haitech Medical Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Device, Rebreathing, Mask, Gas, Anesthetic and 11 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2014.
13device types registered with the FDA
1product
1510(k) clearance
Registration
| Registered name | SHAOXING HAITECH MEDICAL PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010889742 |
| FEI number | 3010889742 |
| DUNS | 421347541 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 绍兴海科医疗用品有限公司 |
|---|---|
| Unified social credit code | 91330600793396913X |
| Source | NMPA UDI database |
Location
| City | Shaoxing |
|---|---|
| Province | Zhejiang |
| Address | No.201, Building 4, 1423 Renmin East Road |
| Postal code | 312035 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | 889901; 889902; 889903; 889904; 889905, Laryngeal Airway Mask | 2014 | 84 |
| Cannula, Nasal, Oxygen | Class 1 | 1810002, Nasal Oxygen Cannula | 2022 | 97 |
| Catheters, Suction, Tracheobronchial | Class 1 | Closed Suction Catheter/System, 8805505A; 8805506A; 8805508A; 880550.10A; 880550.12A; 880550.14A; 880550.16A; 880550.18A, 7880550.10A; 7880550.12A; 7880550.14A; 7880550.16A | 2014 | 93 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | 880501; 880504; 880508, Disposable Anaesthesia Breathing Circuits | 2014 | 55 |
| Condenser, Heat And Moisture (Artificial Nose) | Class 1 | Disposable Bacterial Viral Filter; 880529; 880529HB, HME Filter; 880530; 880531; 880530.C; 880530.B; 880530.10; 880530TA; 880530TB, Catheter Mount; 880551.10; 880551.11; 880551.12 | 2014 | 29 |
| Device, Fixation, Tracheal Tube | Class 1 | 880541TS; 880541TM; 880541TL; 880541TXL, Tracheotomy Tube Holder | 2015 | 46 |
| Device, Rebreathing | Class 1 | Breathing BAG, 880522; 880523; 880524; 880525; 880526; 880527; 880543 | 2014 | 13 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | Breathing circuit bacterial/viral filter | 2024 | 15 |
| Mask, Gas, Anesthetic | Class 1 | Disposable Anaesthesia Mask, 880536; 880537; 880538; 880539; 880540; 880541 | 2014 | 71 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Mask, 1810001 | 2022 | 46 |
| Staple, Removable (Skin) | Class 1 | HT-31, Skin Staple Remover | 2015 | 20 |
| Support, Breathing Tube | Class 1 | Endotracheal Tube Holder, 880541 | 2015 | 14 |
| Syringe, Irrigating (Non Dental) | Class 1 | HT-98010; HT-98011; HT-98012; HT-98013; HT-98014, Disposable Irrigation Syringe | 2014 | 110 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Breathing Circuit Bacterial/Viral Filter | CAH | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K222917 | 2024-02-15 | CAH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Employees | 200+ |
| Main products | Irrigation syringes, Bacteria filters, Closed suction catheters, Spinal needles, Medical circuits |
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.
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