BEUDAMED
    FDA Registration Active 🇨🇳 China

    S403S-42D0

    Reg #: 3007699081 · FEI: 3007699081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    368
    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
    K082846

    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
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    S403S-42D0 A1418-SR203MU05 A1418-SA08D S310-08L0 S810-960 S110S-080 A1422-SA173PV A1418-SP03M02 A1315-SN02M S403S-62D0 A0209-SA127PV S460-70P0 A1422-SP173PV A1418-SA203MU06 A0212-SP02 A1414-SA203PU02 A1418-SR114MU S410S-62D0 A1902-SA135PV A0212-SR125PU01 A0816-SA106PU01 10273 A1919-SA119PV S110-210 A1414-SI103PU01 A1315-SN09M A1424-SR108PU02 9005SMC S410-190 A1315-SR144MU A1424-SA108PV02 A1418-SA203PU03 A0212-SA203PV01 A0424-SA101PV A0424-SA203PU A0424-SA203PV A0424-SP101PU A0424-SP101PV A0424-SP203PU A0424-SP203PV A0309-SA111PV A0309-SA102PV A1311-SA103PV A1311-SP103PU A1311-SP103PV A1311-SW103PU A1418-SA203PU A1418-SA203PV A1418-SP203PU A1418-SP203PV A0101-SA110PU A1318-SA111PV A1318-SA129PU A1318-SA129PV A1318-SP111PU A1318-SP111PV A1318-SP129PU A1318-SP129PV A1318-SW111PU A0101-SW110PU A0209-SP203PU A0405-SP115PV A0405-SP203PU A0405-SP203PV A0405-SW115PU A0405-SW203PU A0424-SA101PU A0424-SW101PU A0424-SW203PU A0509-SA111PU A0509-SA111PV A0509-SP111PU A0509-SP111PV A0509-SW111PU A1318-SA111PU A0209-SA130PU A0319-SP125PU A0319-SP125PV A0319-SW125PU A0405-SA115PU A0405-SA115PV A0405-SA203PU A0405-SA203PV A0405-SP115PU A0219-SW123PU A0101-SP110PV A0219-SP123PV A0309-SA102PU A1318-SW129PU A0705-SA104PU A0705-SA104PV A0705-SP104PU A0705-SP104PV A0705-SW104PU A0209-SA130PV A0219-SA123PV A0309-SA111PU A1111-SP129PV A1111-SW129PU A1114-SA110PU A1114-SA110PV A1114-SP110PU A1114-SP110PV A1114-SW110PU A1311-SA103PU A0101-SP110PU A0101-SA110PV A0209-SP203PV A0209-SA203PU A0309-SA202PV A0816-SA105PU A0816-SA105PV A0816-SA106PU A0816-SA106PV A0816-SP105PU A0816-SP105PV A0816-SP106PU A0219-SA123PU A1023-SA111PU A1023-SA111PV A1023-SA125PU A1023-SA125PV A1023-SP111PU A1023-SP111PV A1023-SP125PU A0219-SP123PU A1023-SP125PV A1023-SW111PU A1023-SW125PU A1111-SA129PU A1111-SA129PV A1111-SP129PU A0209-SW203PU A0309-SP102PU A0309-SP102PV A0309-SP111PU A0309-SP111PV A0309-SP202PU A0309-SP202PV A0309-SW102PU A0309-SW111PU A1418-SW203PU A1418-SA01 A1418-SP01 A0209-SW130PU A0209-SA203PV A0309-SW202PU A0314-SA113PU A0314-SA113PV A0314-SP113PU A0314-SP113PV A0314-SW113PU A0319-SA125PU A0319-SA125PV PR-A520-1011N PR-E600-1011N PR-A900-1011N PR-A120-1011N PR-A220-1011N PR-A520-1016 A0209-SP130PU A0209-SP130PV PR-A120-1005 PR-A520-1005 PR-A520-1005N PR-A220-1005 PR-A220-1005N PR-A900-1005 PR-A120-1005N A1424-SA108PV A1315-SA104PV A1315-SA104PU A1315-SP104PV A1315-SP104PU A1315-SW104PU A0309-SA202PU A0816-SP106PV A0816-SW105PU A0816-SW106PU A0915-SA113PU A0915-SA113PV A0915-SP113PU A0915-SP113PV A0915-SW113PU PR-A120-1001N PR-A520-1001N PR-A900-1001N A0816-SA206PU A0816-SA206PU01 PR-A520-1006V PR-A900-1006 PR-A900-1006V PR-A850-1006V PR-A800-1006V PR-A900-1006V10 PR-A520-1002 PR-A520-1002L PR-A520-1002N PR-A520-1004N PR-A520-1004 A1418-SP203MU A1414-SI01 A1414-SI02 A1414-SI03 A1418-SA02 A1418-SW203MU A1418-SA103MV A1418-SP103MV A1418-SN07 A1418-SN02M A1418-SN01 A1418-SR203PU A1418-SI02 A1418-SI01 A1418-SN03M A1414-SN01 A1414-SN02 A1414-SN03 A2520-SN07 A1414-SP01 A1414-SP02 A1414-SP03 A1418-SP02M A1418-SA203MV A1414-SP103PV A1418-SN01M A1414-SI103PU A1418-SA03 A1418-SR203MU A0212-SW103PU A1418-SI01M A1315-SN03 A1418-SP03M A1418-SA203MU A1418-SP203MV A1418-SP02 A1418-SI02M A1414-SA203PV A1414-SA203PU A1414-SP203PV A1414-SP203PU A1414-SI203PU A1414-SR203PU A1414-SW203PU A1418-SN02 A1418-SN07M A1414-SA01 A1414-SA02 A1414-SA03 A1418-SN03 A1418-SA01M A1418-SA03M A1418-SI03 A1418-SP01M A1418-SI03M A1418-SP03 A1418-SA02M S460-090 S110S-090 A1414-SE103PU DTG-MAXA-A A1414-SA103PV A1315-SN03M S410-21P0 A1414-SP103PU A1414-SA103PU A1414-SW103PU S310-70P0 S403-62D0 S523-080 DTG-MAXN-A S410-65D0 S543-060 S410-290 S110S-290 S203S-010 A1315-SA203MV A1202-SA164PV S103-490 S523-060 10270 S403-720 10497 10196 S110-290 S410-46D0 S410-212P0 A1315-SP01M A1315-SI02M A1315-SA203PV S110S-21M0 S410-750 S203S-01P0 S503-060 S533-060 10468 S403S-090 S410S-090 S410-191P0 S503-490 S503-080 S303-1170 S103-1170 S403-490 S403-1270 S523-010 S523-160 S533-1170 S523-1170 S523-1270 10188 S803-62D0 S410-210 S103-080 10191 S803-080 10219 S803-060 10192 10724 S903-1250 S910-150 S543-050 10199 S110-090 S803-42D0 S910-1210 S903-080 S410-020 S110-01P0 S810-750 S523-090 S503-090 S543-010 S403-01P0 S303-42D0 S543-080 S410S-1370 S310-46D0 S303-910 S403-080 S403-010 10498 10499 S310-01P0 S401-1050 S410-370 S810-205D0 S523-050 S110S-020 S410-600 10197 S410-91M0 S110S-750 S403S-2030 MAS-LNCS Adtx S810-70P0 S910-21M0 S410-205D0 S910-020 S410-090 S110S-050 S523-1250 S410S-21P0 10575 10496 S903-08T0 S310-960 S410-1750 S410-01P0 10238 S503-050 10194 S410S-910 S103S-080 S410-08L0 10600 S305-160 S110-150 10181 S410S-01P0 S310-01P0 S103-01P0 S403S-080 S110-020 S203S-910 S903-010S410S-200 S110S-910 S403-910 S533-020 S303-490 S410-21M0 S403S-070 S503-1170 S410-910 S803-08T0 S310-080 S543-1170 10190 10453 S533-490 S543-490 S523-490 S403-490 S403S-490 S403-1250 S410-150 S410S-21M0 S110-750 S410-62D0 S410-070 10300 S410-97D0 S403-1170 S503-62D0 S543-62D0 S523-01P0 SPP-DA-1M S903-01P0 S803-01P0 S903-910 S910-08L0 S910-090 S903-060 S410-690 S810-01P0 S410S-230 S403-090 9005SP-00 9005SPC-00 S810-191P0 S403S-060 S810-212P0 10189 S110S-600 S303-060 S903-090 S903-1170 S903-1270 S910-750 10495 S503-070 S403S-910 S410-050 A1414-SA0301 S410S-750 S410S-290 10460 S403S-01P0 S103S-01P0 S410-70P0 S803-010 S803-490 S303-01P0 S403-060 S103S-490 S303-080 S503-01P0 S533-01P0 S543-01P0 S910-070 S903-490 S203S-490 10455 10453 MAS-2329 S810-150 S533-010 S410-1210 S410S-480 S110S-01P0 S303-020 S410S-1210 S403S-750 10274 S103-060 10501 S410S-65D0 10305 S410-68D0 S310-020 S503-1250 S533-050 S533-080 A1315-SN03TM S310-750 S810-65D0 MAS-2319 MAS-LNCS Pdtx S103-1250 S110S-208D0 S203S-060 S103S-060 S310-010 S103S-1170 S410S-080 S110-1210 S523-42D0 10244 S810-91M0 A1315-SA03 A1315-SP03 A1315-SI03 S810-1210 S533-1250 S910-910 S410S-210 S810-480 U1M03-49R S410-66D0 S110-66D0 S810-010 S110-46D0 S903-750 S403S-1170 A1418-SN03M04 10500 S110S-91M0 S310-65D0 S310-150 S110S-08L0 S410-208D0 A1315-SR203MU S403S-010 S410-2130 A0212-SP203PV02 A0212-SW203PU01 NE-D-YSPD-SOFT-NC S410S-1750 A0816-SR206PU S310-060 S403-42D0 S810-600 S110S-150 S410-30M0 S410-100 S810-08L0 S110S-21P0 A0209-SA126PV S503-020 S543-090 S503-1270 S543-1270 S810-290 S810-46D0 10306 S410-1470 10470 A1315-SW114MU S310-1210 10506 S533-070 91100 EBS A0212-SP203MU A1318-SP140PV 91099 EBS S110-010 S410-29M0 S401S-1050 S310-910 S103-010 S410-1370 10454 S410-740 S410-480 S103S-910 S110S-70P0 S910-2130 S523-070 S410S-060 A1418-SA03M02 A1315-SA144MU01 A0209-SR203PU S110S-1750 A0816-SR106PU A1418-SA203MV09 S110-205D0 S310-165D0 10062 A1315-SA203MU A0209-SA203PV01 A1414-SA0901 S410S-84D0 NE-DS100A S203S-080 A0212-SP03 9005SP A0418-SA169MV S410S-165D0 A0212-SP01 S810-080 S410-220 S310-220 S110S-220 S403S-750 S410-960 S410S-08L0 A0212-SP149MV S403-020 S533-090 S410-060 S110-640 S910-205D0 S410-330 10105 S910-050 10187 S410S-310 S303-010 S103S-010 A1414-SA203PU01 A1315-SI03M A1802-SA126PV S810-2130 S310-090 S460-030 S410S-220 A0212-SA03 A0212-SA203MU A1318-SA174MV NONIN-7000A S410-17M0 S410S-205D0 A1418-SN03M06 S103-62D0 A1202-SA125PV A0212-SA149MV A1318-SR129PU S810-66D0 A1418-SA114MV NE-DS100A-NC A1501-SA104PV S103S-750 S403-750 S503-010 S410S-010 S410-490 S410-030 S103-020 MAS-2319-NC Mas-2329-NC MAS-LNCS PDTX-NC MAS-LNCS ADTX-NC MAS-1863 MAS-1864 A0209-SR203PU02 A1919-SP119PV S403-150 S401S-070 S910-600 10193 U4M03-01P A1315-SW203MU MAS-2653 BCI-1301 BCI-1303 U4M10S-91 A0816-SA184PV S810-060 S910-960 S543-1250 S810-62D0 S110S-690 S110S-66D0 S503-42D0 A0212-SA02 S110S-191P0 NE-DS100A-SOFT-NC A1315-SA03M S410S-70P0 S110-21P0 S910-470 S410S-191P0 10198 A0916-SA163PV A1418-SA203PVF S110-91M0 S410S-91M0 A2511-SA166PV A0916-SA126PV S110S-010 S410-230 S410-84D0 S410S-150 S110-08L0 S410S-212P0 A0916-SW126PU A0412-SA108PV A1315-SA114MV A1318-SW140PU S110S-060 S310-1750 10269 S410S-020 S810-690 A1418-SA203MV08 S543-42D0 MAS-2258 A1414-SN09 S110-1750 10186 A1414-SA203PV03 S410S-61D0 10588 A1315-SP203MV A0212-SA01 S410S-070 S810-090 A1422-SR173PU S110-191P0 S410-137D0

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device