Shenzhen Changke Connect Electronics Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 5 device types, 4 products catalogued, 8 clearances.
Shenzhen Changke Connect Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Blood Pressure Cuff and 3 other device types. 4 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
5device types registered with the FDA
4products catalogued under its own name
8510(k) clearances
Registration
| Registered name | SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017619536 |
| FEI number | 3017619536 |
| DUNS | 529906512 |
| Establishment type | Manufacturer |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street |
| Postal code | 518115 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Reusable NIBP Cuff (model: GCF1200, GCF1202, GCF1203, GCF1204, GCF1205, CK-XT-78243-007, CK-XT-78243-008), Reusable NIBP Cuff (model: CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001, CK-XT-78243-003, CK-XT-78243-005), Reusable NIBP Cuff (model: CK-XT-78211-001, CK-XT-78211-003, CK-XT-78211-005, CK-XT-78211-006, CK-XT-78211-007), Disposable NIBP Cuff (model: CK-XT-88062-001, CK-XT-88062-003, CK-XT-88062-007, CK-XT-88062-008, CK-XT-88062-010), Disposable NIBP Cuff (model: CK-XT-88062-005) | 2020 | 50 |
| Cable, Electrode | Class 2 | Cable,Snap Connector,Disposable,96IN, 2.44m (Model: P01-001-00571), Cable,Snap Connector,Disposable,120IN, 35m (Model: P01-001-00572), Generic Snap Connector Cable (model: P01-001-00578, P01-001-00564, P01-001-00562, P01-001-00563), Cable,Snap Connector,Disposable,72IN, 1.83m (Model: P01-001-00570) | 2021 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | ECG Cable (model: CK-SMD-980A1-05IR2, CK-SMD-980A1-05AR2), ECG Cable (model: CK-SMD-481A1-12AR2, CK-SMD-582A1-03AR2, CK-SMD-A82A1-03AN2, CK-SMD-582A1-05AR2, CK-SMD-982A1-05AR2), ECG Cable (model: P01-001-00545), ECG Cable (model: CK-SMD-582A1-03AN2, CK-SMD-480A1-12AR2), Disposable ECG Cable (model: CK-SMD-12C4-03A6), ECG Cable (model: P01-001-00565) and 1 more | 2020 | 22 |
| Continuous Measurement Thermometer | Class 2 | Disposable Temperature Probe (model: CK-TP-882111-611D, CK-TP-882121-611D) | 2020 | 115 |
| Electrode, Cutaneous | Class 2 | Disposable EEG electrode (P01-001-00575; EEG electrode, Disp, 72IN, 20 sets of 14), Disposable EEG electrode (P01-001-00577; EEG electrode, Disp 120IN, 20 sets of 14), Disposable EEG electrode (P01-001-00566; EEG electrode, Disp, 48IN, set of 10), Disposable EEG electrode (P01-001-00569; EEG electrode, Disp, 120IN, set of 14), Disposable EEG electrode (P01-001-00574; EEG electrode, Disp, 48IN, 20 sets of 10), Disposable EEG electrode (P01-001-00567; EEG electrode, Disp, 72IN, set of 14) and 2 more | 2022 | 47 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Changke Connect | GXY | 8 |
| Changke Connect | IKD | 7 |
| Changke Connect | DSA | 7 |
| Changke Connect | DXQ | 5 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K213884 | 2022-05-06 | GXY | Abbreviated | This company |
| K193625 | 2020-07-24 | FLL | Traditional | This company |
| K200026 | 2020-05-12 | DSA | Traditional | This company |
| K193629 | 2020-03-25 | DXQ | Traditional | This company |
| K200069 | 2020-03-13 | DQA | Traditional | This company |
| K191428 | 2019-11-27 | DSA | Traditional | This company |
| K191420 | 2019-10-11 | DQA | Traditional | This company |
| K191253 | 2019-09-17 | DXQ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Employees | 200+ experts, 20+ senior engineers |
| Factory area | 5,000 |
| Main products | Medical External cable, Auto Wire Harness, New energy harness, Medical Internal Cable, Consumer Cable |
| Certifications | CE, FDA, UL, ISO |
| Export markets | Europe, America, Middle East, mainland China |
| 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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