FDA Registration
Active
🇨🇳 China
Blood Pressure Cuff
Reg #: 3007699081
·
FEI: 3007699081
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- APK TECHNOLOGY CO., LTD
- Registration Number
- 3007699081
- FEI Number
- 3007699081
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Floor, B2 Building, Industry of Hengfeng, No. 739, Zhoushi Road, Hezhou, Hangcheng Street, Baoan District, Shenzhen China
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K102825
Owner / Operator
- Firm Name
- APK Technology Co., Ltd
- Operator Number
- 10029153
- Address
- 6 Floor, B2 Building, Hengfeng Industry, Hezhou, Xixiang, Bao'an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518126
- Country
- CN
US Agent
- Business Name
- MID-LINK International Inc.
- Contact Name
- Marco Mu
- Address
- 2219 Rimlang Drive, Suite 301
- City
- Bellingham
- State
- WA
- ZIP
- 98226
- Country
- US
- [email protected]
- Phone
- 702 2095185
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2011-10-25 |
Proprietary Names
Blood Pressure Cuff
A-XT-03W(5)-4
A-XT-01W(11)-403
A-XYJ-01N
A-XT-05W(12)
A-XT-11W(13)
A-XT-03W(8)
A-XT-02W(10) A-XT-02W(9)
A-XT-08W(10) A-XT-08W(9)
A-XT-09W(8)
A-XT-12W(1) A-XT-12W(2) A-XT-12W(3) A-XT-12W(4) A-XT-12W(5) A-XT-12W(7)
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)
A-XT-07W(11)
A-XT-06W(13)
A-XT-07D(11) A-XT-08D(10) A-XT-08D(7) A-XT-08D(9) A-XT-10D(12) A-XT-11D(13) A-XT-12D(1) A-XT-12D(2) A-XT-12D(3) A-XT-12D(4) A-XT-12D(5)
A-XT-01 A-XT-02 A-XT-03 A-XT-04 A-XT-05 A-XT-06 A-XT-07 A-XT-08 A-XT-09 A-XT-10 A-XT-11 A-XT-12
A-XT-10W(12)
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-01W(11)
DCSF1750S-C12
DCSF1740S-C12 DCSF1730S-C12
DCSF1740S-C17
DCSF1750S-C17
A-XT-13
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device