R L Co L T D

FDA Filings

This page includes the latest FDA filings for R L Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3010400996
• FEI Number: 3010400996
• Name: R&L CO., LTD
• Owner & Operator: R&L CO., LTD
• Contact Address: 108, Haan-Ro ; Gwangmyeong KR-41 Gyeonggido 14319 KR
• US Agent:
  • Uju Krallum
  • Onbix Corp US
  • 843 5828036
  • onbixus@gmail.com
• Importing Logistics Registration:
  • Importer: Richway International, Inc.
  • Address: 1314 South King Street, Suite 520 ; HON, HI 96814 UNITED STATES
  • Importer Type: Retailer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 108, Haan-ro ; Gwangmyeong Gyeonggido, 423798 KR
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
Richway Amethyst Hydrogel Face Mask R&L Co., Ltd.	Otc Medication	2019-10-30
Pure C Serum R&L Co., Ltd.	Otc Medication	2019-10-30
Pure C Serum R&L Co., Ltd., CIT CO.,LTD	Otc Medication	2019-10-30
PMN K072534 | IRT R&L CO., LTD	Biomat	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Biobelt	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst Single Biomat	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst Queen Biomat	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst Massage Table (Professional) Biomat	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst King Biomat	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst & Tourmaline Pillow	2017-04-19
PMN K072534 | IRT R&L CO., LTD	Amethyst & Tourmaline Mini Biomat	2017-04-19
NDC 70099-0004 R&L Co., Ltd.	Pure C Serum	2016-12-29
NDC 70099-0003 R&L Co., Ltd.	Pure C Serum	2015-12-15
NDC 70099-0002 R&L Co., Ltd.	Richway Amethyst Hydrogel Face Mask	2015-08-31
IRT R&L CO., LTD	Orgone Biomat	2014-05-27

Similar & Related FDA Registered Companies

• Rheater Electronics Co., Ltd
• Rongchenglixin medical supplies (Beijing) Co., Ltd
• Rael Korea Co., Ltd.
• Ralon Medical Equipment Co., Ltd.
• RAPHA Medical CO., Ltd
• Raymond (nantong) protection supplies co., LTD
• RAYMOND CHU INTL. (MACAO COMMERCIAL OFFSHORE) LTD
• Real Sports Enterprise Co., Ltd.
• REALEEN BIOTECHNOLOGY (ZHEJIANG)CO.,LTD
• Reborn Medical Co., Ltd.
• Recovery Home Medical Devices (Beijing) Co., Ltd.
• Red-crowned Crane Intelligent Technology(Jiangsu) Co.,Ltd
• Refine Home Textile Co., Ltd.
• Refirmance Athletic Protector Co., Ltd.
• Regent Electron Suzhou Co., Ltd
• Rehab Italian Design Co., Ltd.
• RELEGEND EYEWEAR CO., LTD.
• Reliance Medical (Shanghai) Co., Ltd
• Resplendent (Shanghai) New Material Technology Co., Ltd
• RF MEDICAL CO., LTD
• RFX Pharmaceutical Co,(guangxi)Ltd
• Rich Resource Global Supply Chain (Guangzhou) CO.,LTD
• Richfields Corp. Ltd.
• RICOEUR,Shangyou,Pharmaceutical Technology Co.,Ltd
• RIVAL VIETNAM CO.,LTD
• Riverside Medical Packaging Company Ltd
• RIVIERA OPTICAL CO., LTD.
• RIZHAO SANQI MEDICAL & HEALTH ARTICLES CO., LTD
• RJ Healthcare Co., Ltd
• ROCKBROOK DAILY PRODUCTS CO., LIMITED
• Rongcheng hengxin medical equipment co., LTD
• Rongcheng RV Homeland Technology Co., Ltd.
• Rongqi Medical Devices (Shanghai) Co., Ltd.
• Rongxing Plastic Jurong Co.,Ltd.
• Roosin Medical Co., Ltd.
• RootLoc Co., Ltd.
• RoShung International Co, Limited
• Royal Champion Commodity Co.,Ltd.
• ROYAL FORKLIFT (JIANGSU)CO.,LTD
• RU SAN OPTICAL IND CO LTD.
• Rugao Dongfeng Glove Co.,Ltd.
• rugao feida handicraft-article co;ltd
• Ruian Bote Science And Technology Co.,Ltd.
• Ruian BoYu Automobile Parts Co., Ltd Pingyang Branch
• RUIAN CITY DE LI MASK CO.,LTD.
• Ruian E-cozy Electronic Technology Co.,Ltd.
• Ruian Fangren Technology Co., Ltd.
• RUIAN HALLELUJAH PROTECTIVE EQUIPMENT CO LTD
• Ruian Leimaisi Fitness Equipment Co., Ltd.
• Ruian rongman Medical Equipment Co., Ltd
• RUIAN SANZHENG LUGGAGE LEATHER GOODS CO.,LTD
• RUIAN TONGDA OPTICAL CO., LTD
• RUIAN WISELY TECHNOLOGY CO LTD
• RUIAN YUEXIANG MEDICAL EQUIPMENT CO., LTD.
• Ruichang junwei medical equipment co.LTD
• Ruichang Kangde Medical Equipment Co., Ltd
• Ruimin (Shanghai) Industrial Co., Ltd
• Runtai rescue equipment technology Hebei Co., Ltd.
• Runto Medical Products Co.,Ltd.
• RUY-NK TEXTILE CO., LIMITED
• Ruzhou Wonderful Medical Instruments Co.,Ltd
• Rizhao HuGe Biomaterials Company, Ltd.
• Realton (Suzhou) Medical Technology Co., Ltd.
• Real Star Medical Technology Co., Ltd.
• Reed Medical (Zhejiang) Co., Ltd.
• Roosin Medical Devices Co., Ltd
• RIZHAO HUGE DENTAL INDUSTRY CO., LTD
• RONGYAO PLASTIC PRODUCE CO., LTD
• RIO FLEXON TECHNOLOGY CO., LTD.
• ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD.
• R. POON MEDICAL PRODUCTS CO., LTD.
• ROYAL KING INFANT PRODUCTS CO. LTD.
• ROLENCE ENTERPRISE CO. LTD.
• ROYAL FLASH ENTERPRISE CO. LTD.
• REGULATORY CONSULTANTS TO THE MEDICAL DEVICE INDUS
• RUSSELL & HANCOCK, LTD.
• RUHN CHANG INDUSTRIAL CO., LTD.
• REX LATEX PRODUCTS CO., LTD.
• RELIANCE INDUSTRIAL CO., LTD.
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP090008 Supplement NumberS023 Date Received09/30/2022 Decision Date01/24/2023 Reclassified Date 12/22/2021 Product Code MZO  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE MOLECULAR SYSTEMS, INC.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP160041 Supplement NumberS035 Date Received05/31/2022 Decision Date12/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Resolution Bioscience, Inc.550 Kirkland Way, Suite 200kirkland, WA 98033 PMA NumberP210040 Date Received12/28/2021 Decision Date12/12/2022 Product Code PQP  Advisory Committee Clinical TrialsNCT03785249 Expedited Review Granted? No
• RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS026 Date Received11/09/2022 Decision Date11/30/2022 Product Code PZK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular System, Inc.4300 Hacienda Drivepleasanton, CA 94588 PMA NumberP200014 Supplement NumberS004 Date Received10/18/2022 Decision Date11/29/2022 Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ROCHE4300 Hacienda Drivepo Box 9002pleasanton, CA 94588 PMA NumberP120019 Supplement NumberS034 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP140023 Supplement NumberS025 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110037 Supplement NumberS057 Date Received10/21/2022 Decision Date11/14/2022 Product Code PAB  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP110020 Supplement NumberS037 Date Received10/21/2022 Decision Date11/14/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP100020 Supplement NumberS054 Date Received10/21/2022 Decision Date11/14/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Roche Molecular Systems, Inc.4300 Hacienda Drivepleasanton, CA 94588-2722 PMA NumberP050028 Supplement NumberS086 Date Received10/21/2022 Decision Date11/14/2022 Product Code MKT  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• RAYNER INTRAOCULAR LENSES LTD.1-2 Sackville Trading Estate,sackville Roadhove, East Sussex BN3 7 PMA NumberP060011 Supplement NumberS030 Date Received07/21/2022 Decision Date08/15/2022 Product Code HQL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ReShape Lifesciences, Inc.1001 Calle Amanecersan Clemente, CA 92673 PMA NumberP160001 Supplement NumberS047 Date Received01/19/2022 Decision Date07/18/2022 Product Code LTI  Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• RxSight, Inc.100 Columbiaaliso Viejo, CA 92656 PMA NumberP160055 Supplement NumberS023 Date Received06/09/2022 Decision Date07/05/2022 Product Code PZK  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100032 Supplement NumberS021 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• ROCHE DIAGNOSTICS CORP.9115 Hague Rd.indianapolis, IN 46250 PMA NumberP100031 Supplement NumberS027 Date Received09/30/2021 Decision Date04/04/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• RACHEL K COSMETICS PTE. LTD.
• RED WINGS INDUSTRIAL CO., LIMITED
• RENOCELL Co., Ltd
• Reward Daily Chemical (Jiangsu) Co., Ltd.
• Reynard (Ningbo) Biotechnology Co., Ltd.
• RFX Pharmaceutical Co Ltd
• Rhodia Wuxi Pharmaceutical Co., Ltd.
• RITZY NOBLE CO., LTD.
• ROCKET ELECTRIC CO., LTD.
• Rohto Pharmaceutical Co., Ltd.
• Rohto-Mentholatum (Vietnam) Co. Ltd.
• Royal Chemical Company, Ltd.
• Royal Springs Cosmetic Co., Ltd.
• RUBELLI CO.,LTD
• Rudder Int'l Trading (Shanghai) Co., Ltd.
• Ruian Information Technology (Guangdong) Co., Ltd.
• CIT CO.,LTD
• Riton 3D Technology Co., Ltd
• Rhein Laser Technologies Co.,Ltd.