This page includes the latest FDA filings for Kobayashi America Manufacturing L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Kobayashi America Manufacturing L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3003079019 |
| FEI Number | 1000112007 |
| Name | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Owner & Operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Contact Address | 245 KRAFT DRIVE Dalton GA 30721 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 245 KRAFT DR Dalton, GA 30721 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3002965034 |
| FEI Number | 3002965034 |
| Name | HEFEI KOBAYASHI DAILY PRODUCTS CO., LTD. |
| Owner & Operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Contact Address | 245 KRAFT DRIVE Dalton GA 30721 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | NO. 99 SHENGWU YIYAOZHI ROAD HIGH-TECH ZONE HEFEI Anhui, 230088 CN |
| Establishment Type | Manufacture Medical Device |
| Registration Number | 1054358 |
| FEI Number | 1000112007 |
| Name | KOBAYASHI CONSUMER PRODUCTS, LLC d/b/a HEATMAX, INC. |
| Owner & Operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Contact Address | 245 KRAFT DRIVE Dalton GA 30721 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 245 Kraft Dr DALTON, GA 30721 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
| Registration Number | 3004201320 |
| FEI Number | 3004201320 |
| Name | Scott A Hughes |
| Owner & Operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Contact Address | 245 KRAFT DRIVE Dalton GA 30721 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 245 Kraft Drive Dalton, GA 30721 US |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
| Registration Number | 3002324535 |
| FEI Number | 3002324535 |
| Name | KOBAYASHI PHARMACEUTICAL CO., LTD. |
| Owner & Operator | KOBAYASHI AMERICA MANUFACTURING, LLC |
| Contact Address | 245 KRAFT DRIVE Dalton GA 30721 US |
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | KDX Kobayashi Doshomachi Bldg 4-10, Doshomachi 4-chome Chuo-ku Osaka, 541-0045 JP |
| Establishment Type | Export Device to the United States But Perform No Other Operation on Device |
Device Company | Device | Date |
|---|---|---|
| Kobayashi Healthcare International, Inc., Kobayashi America Manufacturing, LLC | Otc Medication | 2024-12-11 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2023-11-17 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2023-11-17 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2022-12-09 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2022-09-22 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2022-09-01 |
KOBAYASHI PHARMACEUTICAL CO., LTD. [KOBAYASHI AMERICA MANUFACTURING, LLC] | Beyond Sleep | 2019-09-04 |
KOBAYASHI CONSUMER PRODUCTS, LLC d/b/a HEATMAX, INC. [KOBAYASHI AMERICA MANUFACTURING, LLC] | Beyond Sleep | 2019-09-04 |
KOBAYASHI AMERICA MANUFACTURING, LLC | Beyond Sleep | 2019-09-04 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2019-05-15 |
| KOBAYASHI Healthcare International, Inc., KOBAYASHI America Manufacturing, LLC | Otc Medication | 2018-11-20 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020092522557 | Tokyo ,Japan -> Los Angeles, California | PLASTIC FILM ROLL | 1226 ROL |
| 2020092522557 | Tokyo ,Japan -> Los Angeles, California | PLASTIC FILM ROLL | 1226 ROL |
| 2020092554140 | Tokyo ,Japan -> Los Angeles, California | NONWOVEN FABRIC ROLL | 400 ROL |
| 2020092280008 | Stadersand,Federal Republic of Germany -> Savannah, Georgia | IRON POWDER 20 FLEXBAGS OF IRON POWDER HS 72052900 | 80 PCS |
| 2020092280008 | Stadersand,Federal Republic of Germany -> Savannah, Georgia | IRON POWDER 20 FLEXBAGS OF IRON POWDER HS 72052900 | 80 PCS |
| 2020092280008 | Stadersand,Federal Republic of Germany -> Savannah, Georgia | IRON POWDER 20 FLEXBAGS OF IRON POWDER HS 72052900 | 80 PCS |
| 2020092280008 | Stadersand,Federal Republic of Germany -> Savannah, Georgia | IRON POWDER 20 FLEXBAGS OF IRON POWDER HS 72052900 | 80 PCS |
| 2020091817255 | Nagoya Ko ,Japan -> Los Angeles, California | HEATING PAD 1 SANFRESH K-31 | 640 BAG |
| 2020091852798 | Nagoya Ko ,Japan -> Los Angeles, California | POROUS POLYETHYLENE FILM | 468 CTN |
| 2020091733346 | Tokyo ,Japan -> Savannah, Georgia | NON-WOVEN FABRIC | 399 ROL |
| 2020091747267 | Laem Chabang,Thailand -> Long Beach, California | (8 PALLETS) US. ONEDROP.MINT SCENT 30, 000 PCS H.S. CODE 330749 | 8 PKG |
| 2020091674062 | Shanghai ,China (Mainland) -> Savannah, Georgia | BE KOOOL HOTHANDS | 13890 CTN |
| 2020091674062 | Shanghai ,China (Mainland) -> Savannah, Georgia | BE KOOOL HOTHANDS | 13890 CTN |
| 2020091674062 | Shanghai ,China (Mainland) -> Savannah, Georgia | BE KOOOL HOTHANDS | 13890 CTN |
| 2020091674062 | Shanghai ,China (Mainland) -> Savannah, Georgia | BE KOOOL HOTHANDS | 13890 CTN |