Shenzhen Insighters Medical Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 10 device types, 10 products catalogued, 3 clearances.
Shenzhen Insighters Medical Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Laryngoscope, Rigid, Stylet, Tracheal Tube and 8 other device types. 10 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
10device types registered with the FDA
10products catalogued under its own name
3510(k) clearances
Registration
| Registered name | SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013528571 |
| FEI number | 3013528571 |
| DUNS | 551096917 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳因赛德思医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440300088533919A |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 13th, HTM Building, Ganli Road |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Model:iSLMAVA15Y 1.5#;iSLMAVA20Y 2#;iSLMAVA25Y 2.5#;iSLMAVA30Y 3#;iSLMAVA40Y 4#;iSLMAVA50Y 5#, Model:iSLMAB10 1#;iSLMAB15 1.5#;iSLMAB20 2#;iSLMAB25 2.5#;iSLMAB30 3#;iSLMAB40 4#;iSLMAB50 5#, Laryngeal Mask Airway, Model: iS-LMA-A30, iS-LMA-A40, S-LMA-A50, Model:iSLMAC10 1#;iSLMAC15 1.5#;iSLMAC20 2#;iSLMAC25 2.5#;iSLMAC30 3#;iSLMAC40 4#;iSLMAC50 5#, Model:iSLMAA10 1#;iSLMAA15 1.5#;iSLMAA20 2#;iSLMAA25 2.5#;iSLMAA30 3#;iSLMAA40 4#;iSLMAA50 5# and 4 more | 2021 | 84 |
| Bronchoscope (Flexible Or Rigid) | Class 2 | Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5/2.6, Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6/3, Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2, Single-use Flexible Video Bronchoscope, Insighters™ Insight Workstation iS-PF 1 | 2025 | 21 |
| Catheters, Suction, Tracheobronchial | Class 1 | Disposable Closed Suction Catheter, Long-acting Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr, Child Type: 6Fr,8Fr, Standard Type: 6Fr,8Fr,10Fr,12Fr,14Fr,16Fr, Disposable Suction Catheter,Model:iSKX06 6Fr;iSKX08 8Fr;iSKX10 10Fr;iSKX12 12Fr;iSKX14 14Fr;iSKX16 16Fr | 2021 | 93 |
| Connector, Airway (Extension) | Class 1 | Tracheal Tube Adapter, Model: QT01 | 2021 | 20 |
| Instrument, Ent Manual Surgical | Class 1 | Disposable Blade | 2016 | 11 |
| Laryngoscope, Non-Rigid | Class 1 | Video Flexible Laryngoscope,Model: iS3-C; iS3-FN2; iS3-F; iS3-C4; iS3-C5; iS3-C6; iS3-F2; iS3-F3;iS-B01 | 2016 | 12 |
| Laryngoscope, Rigid | Class 1 | Video Laryngoscope,Model: iS3-L, Video Rigid Laryngoscope, Model: iS3-R, Video Laryngoscope, Model: insight iS6, Video Laryngoscope, Model: insight iS2, Video Laryngoscop Accessory-3.5 inch Host (iS6-M), Video Laryngoscope Accessory-Power Adapter and 7 more | 2016 | 44 |
| Medical Device Data System | Class 1 | Insight Workstation, Model: iS-PF1, iS-PF2, Insight Workstation Accessory-Trolley:iS-TC1,iS-TC2, Insight Workstation Accessory-Wireless Module, Connection Cable,Power Adapter | 2020 | 11 |
| Stylet, Tracheal Tube | Class 1 | Stylet: insight ST1 | 2022 | 34 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Class 2 | Disposable Endobronchial Blocker Tube:5Fr;7Fr;9Fr, Disposable Double Lumen Endobronchial Tube (Visible Right Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Ordinary Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Ordinary Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Visible Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr), Disposable Double Lumen Endobronchial Tube (Visible Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) and 1 more | 2023 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Insighters | CBI | 39 |
| Insighters | CCW | 9 |
| Insighter | LRC | 8 |
| Insighters | OUG | 7 |
| Insighters | EOQ | 3 |
| Insighter | CAE | 3 |
| Insighter | CAL | 2 |
| Insighter | BSR | 1 |
| Insighter | BSY | 1 |
| Insighters | BZA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242793 | 2025-05-28 | EOQ | Traditional | This company |
| K232529 | 2024-05-13 | CBI | Traditional | This company |
| K232580 | 2023-12-14 | CBI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Factory area | 40000 square meters |
| Main products | Airway management devices, Medical visualization systems, Endoscopy equipment, Telemedicine platform |
| Export markets | 70+ 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.
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