APK Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 6 device types, 22 products catalogued, 7 clearances.
APK Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Cable, Electrode and 4 other device types. 22 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2009.
6device types registered with the FDA
22products catalogued under its own name
7510(k) clearances
Registration
| Registered name | APK TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007699081 |
| FEI number | 3007699081 |
| DUNS | 529691989 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市安普康科技有限公司 |
|---|---|
| Unified social credit code | 91440300752503954U |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 6 Floor, B2 Building |
| Postal code | 518126 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | A-XT-01W(11)-403, Blood Pressure Cuff, A-XT-04W(1) A-XT-04W(2) A-XT-04W(3) A-XT-04W(4) A-XT-04W(5) A-XT-04W(7), A-XT-11W(13), A-XT-06W(13), A-XT-01D(11) A-XT-02D(10) A-XT-03D(9) A-XT-03D(8) A-XT-04D(1) A-XT-04D(2) A-XT-04D(3) A-XT-04D(4) A-XT-04D(5) A-XT-04D(7) A-XT-05D(12) A-XT-06D(13) and 18 more | 2011 | 50 |
| Cable, Electrode | Class 2 | A3010-EC1LT, A6076-EK2MR, I-RLW-05BC-24RA-0000, I-RLW-05BC-24LA-0000, I-RLW-05AL-40V2-0000, I-SLC-4100-510 and 54 more | 2009 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | ECG cables, LW-314DS29/5AS, I-DLP-03BB-40AS-0100, I-DLP-06AF-MXAN-0100, PH-989803173131-S, I-DLP-03BF-36AN-0100 and 55 more | 2017 | 22 |
| Electrode, Electrocardiograph | Class 2 | A-DE-B6060Y-X, A-DE-B6060Y, A-DE-B3035S, A-DE-B4346S, A-DE-B3238S-X, A-DE-B3030Y and 54 more | 2014 | 33 |
| Light, Ultraviolet, Dermatological | Class 2 | AUC004, Ultraviolet phototherapy device | 2025 | 8 |
| Oximeter | Class 2 | A1424-SA108PV02, A0916-SA129PU, A0916-SY163PU04, A0210-SY195PU, A0220-SI178MU, A1202-SP129PU01 A1202-SW129PU01 and 114 more | 2009 | 70 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| APK | DQA | 2,678 |
| APK | IKD | 1,081 |
| APK | DRX | 113 |
| APK | DSA | 87 |
| Blood pressure cuff | DXQ | 59 |
| Nihon Kohden | DQA | 30 |
| Nihon Kohden Disposable | DQA | 12 |
| APK | DXQ | 8 |
| Mindray | IKD | 6 |
| GE-Nellcor | DQA | 5 |
| Nihon Kohden | DSA | 4 |
| Spacelabs | IKD | 3 |
| Mindray | DSA | 2 |
| Philips | IKD | 2 |
| APK | FTC | 1 |
| Kontron | DQA | 1 |
| Philips | DSA | 1 |
| Din ECG | IKD | 1 |
| Reusable ECG Lead Wires for GE | IKD | 1 |
| Spacalabs | IKD | 1 |
| GE | IKD | 1 |
| HP | DQA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K250425 | 2025-04-07 | FTC | Traditional | This company |
| K172981 | 2018-06-08 | DQA | Traditional | This company |
| K170536 | 2017-04-24 | DSA | Traditional | This company |
| K102825 | 2011-03-02 | DXQ | Traditional | This company |
| K082846 | 2009-04-03 | DQA | Traditional | This company |
| K903963 | 1991-07-29 | LRP | Traditional | This company |
| K903962 | 1991-07-29 | LRP | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Factory area | 30,000 square meters |
| Main products | Blood oxygen sensors, Temperature probes, ECG cables, Blood pressure cuffs, EEG sensors |
| Certifications | ISO13485:2016, CE, FDA, CFDA |
| Export markets | Global |
| 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.
The manufacturer named here can complete this record.