This page includes the latest FDA filings for Nanoentek Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| KOREA REP OF | KOREA EXCHANGE (KOSDAQ) | 039860 | DUNS 687910463 |
| Registration Number | 3009092698 |
| FEI Number | 3009092698 |
| Name | NANOENTEK INC |
| Owner & Operator | NanoEnTek Inc |
| Contact Address | 240 Bear Hill Road Suite 101 Waltham MA 02451 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 12F, 5, Digital-ro 26-gil Guro-gu Seoul Seoul Teugbyeolsi, 08389 KR |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
| Registration Number | 3007113174 |
| FEI Number | 3007113174 |
| Name | NANOENTEK AMERICA INC |
| Owner & Operator | NanoEnTek Inc |
| Contact Address | 240 Bear Hill Road Suite 101 Waltham MA 02451 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 240 Bear Hill Road Suite 101 North Waltham, MA 02451 US |
| Registration Number | 3007349751 |
| FEI Number | 3007349751 |
| Name | Jacob Jung |
| Owner & Operator | NanoEnTek Inc |
| Contact Address | 240 Bear Hill Road Suite 101 Waltham MA 02451 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 240 Bear Hill Road, STE 101 Waltham, MA 02451 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| NanoEnTek, Inc. | ADAM-rWBC2 System ADAM-rWBC2 System | 2024-07-23 |
| NanoEnTek, Inc. | ADAM-rWBC2 ADAM-rWBC2 | 2024-07-23 |
| NanoEnTek, Inc. | ADAM-rWBC System ADAM-rWBC System | 2024-07-23 |
| NanoEnTek, Inc. | ADAM-rWBC Kit AD1K-050 | 2024-07-23 |
| NanoEnTek, Inc. | ADAM-rWBC ADAM-rWBC | 2024-07-23 |
| NanoEnTek, Inc. | FREND Free T4 FRT4AP 020 | 2024-07-22 |
| NanoEnTek, Inc. | FREND Vitamin D FRVDAP 020 | 2024-07-22 |
| NanoEnTek, Inc. | FREND Free T4 FRT4 020 | 2024-07-22 |
| NanoEnTek, Inc. | FREND TSH FRTS 025 | 2024-07-22 |
| NanoEnTek, Inc. | FREND System F20 | 2024-07-08 |
| NanoEnTek, Inc. | FREND F10 | 2023-06-19 |
| NanoEnTek, Inc. | FREND FRTEAP 020 | 2023-05-03 |
| NanoEnTek, Inc. | FREND FRTE 020 | 2023-05-03 |
| NanoEnTek, Inc. | FREND F10AP | 2022-06-10 |
| NanoEnTek, Inc. | r-Control RBC and PLT ADRC 020 | 2021-12-16 |
Nanoentek, Inc. | Test, Residual, WBC In Leukoreduced Blood | 2021-10-28 |
| NanoEnTek, Inc. | ADAM ADHK-050 | 2021-02-23 |
| NanoEnTek, Inc. | ADAM | 2021-02-23 |
| NanoEnTek, Inc. | C-Chip DHC-F01 | 2020-11-04 |
| NanoEnTek, Inc. | FREND FLK-VTD | 2020-11-04 |
| NanoEnTek, Inc. | FREND FLK-TSH | 2020-11-04 |
| NanoEnTek, Inc. | FREND FLK-TES | 2020-11-04 |
| NanoEnTek, Inc. | FREND FLK-PSA | 2020-11-04 |
| NanoEnTek, Inc. | FREND FLK-FT4 | 2020-11-04 |
| NanoEnTek, Inc. | FREND FRCOA 020 | 2020-09-10 |
| NanoEnTek, Inc. | FREND FIC-COALQ | 2020-09-10 |
| NanoEnTek, Inc. | ADAM CD34K-050 | 2020-09-10 |
| NanoEnTek, Inc. | ADAM ADAM2 | 2020-09-10 |
| NanoEnTek, Inc. | FREND FRBF 015 | 2020-04-01 |
NANOENTEK INC | FREND Blocking Reagent | 2020-03-16 |
NANOENTEK INC | FRBR 015 | 2020-03-16 |
Jacob Jung [NanoEnTek Inc] | FREND Blocking Reagent | 2020-03-16 |
Jacob Jung [NanoEnTek Inc] | FRBR 015 | 2020-03-16 |
| NanoEnTek, Inc. | FREND FRPS 025 | 2020-02-06 |
| NanoEnTek, Inc. | FREND FRPS 025 | 2020-02-06 |
NANOENTEK INC | ADAMII | 2019-10-09 |
NANOENTEK INC | ADAMII-CD34 Kit | 2019-10-09 |
NANOENTEK INC | ADAMII CD34 System | 2019-10-09 |
Jacob Jung [NanoEnTek Inc] | ADAMII | 2019-10-09 |
Jacob Jung [NanoEnTek Inc] | ADAMII-CD34 Kit | 2019-10-09 |
Jacob Jung [NanoEnTek Inc] | ADAMII CD34 System | 2019-10-09 |
Nanoentek, Inc. | Automated Differential Cell Counter | 2019-08-09 |
| NanoEnTek, Inc. | C-Chip DHC-F0420 | 2019-07-03 |
| NanoEnTek, Inc. | C-Chip DHC-F04 | 2019-07-03 |
| NanoEnTek, Inc. | C-Chip DHC-B0420 | 2019-07-03 |
| NanoEnTek, Inc. | C-Chip DHC-B04 | 2019-07-03 |
| NanoEnTek, Inc. | C-Chip DHC-N0420 | 2019-07-03 |
| NanoEnTek, Inc. | C-Chip DHC-N04 | 2019-07-03 |
NANOENTEK INC | FREND Vitamin D Linearity Kit | 2018-09-10 |
NANOENTEK INC | FREND Testosterone Linearity Kit | 2018-09-10 |
NANOENTEK INC | FREND TSH Linearity Kit | 2018-09-10 |
NANOENTEK INC | FREND PSA Plus Linearity Kit | 2018-09-10 |
NANOENTEK INC | FREND Free T4 Linearity Kit | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | FREND Vitamin D Linearity Kit | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | FREND Testosterone Linearity Kit | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | FREND TSH Linearity Kit | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | FREND PSA Plus Linearity Kit | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | FREND Free T4 Linearity Kit | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-N04 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-N0420 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-N01 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-M01 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-F04 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-F0420 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-F01 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-B04 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-B0420 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-B02 | 2018-09-10 |
NANOENTEK INC | C-Chip DHC-B01 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-N04 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-N0420 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-N01 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-M01 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-F04 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-F0420 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-F01 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-B04 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-B0420 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-B02 | 2018-09-10 |
Jacob Jung [NanoEnTek Inc] | C-Chip DHC-B01 | 2018-09-10 |
NANOENTEK INC | FREND AP | 2018-05-29 |
Jacob Jung [NanoEnTek Inc] | FREND AP | 2018-05-29 |
NANOENTEK INC | FREND System | 2017-05-25 |
NANOENTEK INC | FREND PSA Plus | 2017-05-25 |
Jacob Jung [NanoEnTek Inc] | FREND System | 2017-05-25 |
Jacob Jung [NanoEnTek Inc] | FREND PSA Plus | 2017-05-25 |
NANOENTEK INC | FREND Vitamin D | 2017-01-18 |
NANOENTEK INC | FREND System | 2017-01-18 |
NANOENTEK INC | FREND AP | 2017-01-18 |
Jacob Jung [NanoEnTek Inc] | FREND Vitamin D | 2017-01-18 |
Jacob Jung [NanoEnTek Inc] | FREND System | 2017-01-18 |
Jacob Jung [NanoEnTek Inc] | FREND AP | 2017-01-18 |
NANOENTEK INC | FREND Testosterone | 2016-10-31 |
NANOENTEK INC | FREND System | 2016-10-31 |
NANOENTEK INC | FREND AP | 2016-10-31 |
Jacob Jung [NanoEnTek Inc] | FREND Testosterone | 2016-10-31 |
Jacob Jung [NanoEnTek Inc] | FREND System | 2016-10-31 |
Jacob Jung [NanoEnTek Inc] | FREND AP | 2016-10-31 |
NANOENTEK INC | FREND System | 2016-02-17 |
NANOENTEK INC | FREND Free T4 | 2016-02-17 |
NANOENTEK INC | FREND AP | 2016-02-17 |
Jacob Jung [NanoEnTek Inc] | FREND System | 2016-02-17 |
Jacob Jung [NanoEnTek Inc] | FREND Free T4 | 2016-02-17 |
Jacob Jung [NanoEnTek Inc] | FREND AP | 2016-02-17 |
NANOENTEK INC | FastRapid | 2016-02-03 |
Jacob Jung [NanoEnTek Inc] | FastRapid | 2016-02-03 |
NANOENTEK INC | FREND TSH | 2014-03-16 |
NANOENTEK INC | FREND System | 2014-03-16 |
Jacob Jung [NanoEnTek Inc] | FREND TSH | 2014-03-16 |
Jacob Jung [NanoEnTek Inc] | FREND System | 2014-03-16 |
NANOENTEK INC | ADAM-rWBC2 (automatic white cell counter) | 2013-06-11 |
NANOENTEK INC | AD1K-050 (ADAM-rWBC disposable kit) | 2013-06-11 |
Jacob Jung [NanoEnTek Inc] | ADAM-rWBC2 (automatic white cell counter) | 2013-06-11 |
Jacob Jung [NanoEnTek Inc] | AD1K-050 (ADAM-rWBC disposable kit) | 2013-06-11 |
NANOENTEK INC | FRENDTM System | 2013-06-10 |
NANOENTEK INC | FRENDTM PSA Plus | 2013-06-10 |
Jacob Jung [NanoEnTek Inc] | FRENDTM System | 2013-06-10 |
Jacob Jung [NanoEnTek Inc] | FRENDTM PSA Plus | 2013-06-10 |
NANOENTEK INC | FRENDTM System | 2013-06-10 |
NANOENTEK INC | FRENDTM PSA Plus | 2013-06-10 |
Jacob Jung [NanoEnTek Inc] | FRENDTM System | 2013-06-10 |
Jacob Jung [NanoEnTek Inc] | FRENDTM PSA Plus | 2013-06-10 |
NANOENTEK INC | ADAM-rWBC2 PC Software | 2013-04-12 |
NANOENTEK INC | ADAM-rWBC PC Software | 2013-04-12 |
NANOENTEK INC | ADAM-rWBC HT PC Software | 2013-04-12 |
Jacob Jung [NanoEnTek Inc] | ADAM-rWBC2 PC Software | 2013-04-12 |
Jacob Jung [NanoEnTek Inc] | ADAM-rWBC PC Software | 2013-04-12 |
Jacob Jung [NanoEnTek Inc] | ADAM-rWBC HT PC Software | 2013-04-12 |
Nanoentek, Inc. | Automated Differential Cell Counter | 2012-12-05 |
NANOENTEK INC | ADAM-rWBC2 (automatic white cell counter) | 2012-08-22 |
NANOENTEK INC | AD1K-050 (ADAM-rWBC disposable kit) | 2012-08-22 |
Jacob Jung [NanoEnTek Inc] | ADAM-rWBC2 (automatic white cell counter) | 2012-08-22 |
Jacob Jung [NanoEnTek Inc] | AD1K-050 (ADAM-rWBC disposable kit) | 2012-08-22 |
Nanoentek, Inc. | Automated Differential Cell Counter | 2012-07-24 |
Nanoentek, Inc. | Automated Blood Grouping And Antibody Test Systems | 1995-11-29 |
| CAGE Code | 55WS8 | NANOENTEK INC MARKETING AND SALES |
| CAGE Code | 7VZU4 | NANOENTEK, INC. NANOENTEK AMERICA |
| S.A.M. Registration | 7VZU4 [80693077] | NANOENTEK, INC. |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020070111615 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 10 PKG |
| 2020052520370 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 10 PKG |
| 2020041823274 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 20 PKG |
| 2020012113726 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 11 PKG |
| 2020012115205 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 14 PKG |
| 2019102815054 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 14 PKG |
| 2019072313140 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 7 PKG |
| 2019072217551 | Pusan,South Korea -> Baltimore, Maryland | ELECTROPORATION DEVICE MICROPORATOR | 16 PKG |