Ocean Well Co L T D

FDA Filings

This page includes the latest FDA filings for Ocean Well 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 Number3007125287
FEI Number3007125287
NameOCEAN WELL CO., LTD.
Owner & OperatorOCEAN WELL Co., Ltd.
Contact Address1st Industrial Area, Bao-Tang, Hou-jie Town, Dongguan City, Guangdong, China
Dongguan CN-44 Guangdong 523955 CN
Official Correspondent
  • Chang James
  • 86-769-85815436-x
US Agent
Importing Logistics Registration
ImporterDARCO INTERNATIONAL INC.
Address810 MEMORIAL BLVD. HUNTINGTON
Huntington, WV 25701 UNITED STATES
Importer TypeAgent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1st Industrial Area, Bao-Tang, Hou-jie Town, Dongguan City, Guangdong, China
Dongguan Guangdong, 523955 CN
Establishment TypeManufacture Medical Device



Registration Number3016099034
FEI Number3016099034
NameOcean Well Footwear Co., Ltd.
Owner & OperatorOCEAN WELL Co., Ltd.
Contact Address1st Industrial Area, Bao-Tang, Hou-jie Town, Dongguan City, Guangdong, China
Dongguan CN-44 Guangdong 523955 CN
Official Correspondent
  • Chang James
  • 86-769-85815436-x
US Agent
Importing Logistics Registration
ImporterAMERX HEALTH CARE
Address1300 South Highland Avenue
Clearwater, FL 33756 UNITED STATES
Phone1 800 4489599
FAX1 727 4475617
Importing Logistics Registration
ImporterDARCO INTERNATIONAL INC.
Address810 MEMORIAL BLVD
Huntington, WV 25701 UNITED STATES
Phone1 304 5224883
FAX1 304 5220037
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressNo.61, Alley136, Lane 268, Sec.3 Fengyuan Blvd, Fengyuan Dist.
Taichung Taichung - District, 420 TW
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
FQL - STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)2017-08-31
OCEAN WELL CO., LTD.
FQL - STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)2017-08-31
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
JOINT, ANKLE, EXTERNAL BRACE2017-04-12
OCEAN WELL CO., LTD.
JOINT, ANKLE, EXTERNAL BRACE2017-04-12
OCEAN WELL CO., LTD.
Protector, skin pressure2017-04-12
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
Sotie Shoes2009-02-12
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
Medical Surgical Shoe, Classic Post Op, Soft Touch Post Op2009-02-12
OCEAN WELL CO., LTD.
Sotie Shoes2009-02-12
OCEAN WELL CO., LTD.
Medical Surgical Shoe, Classic Post Op, Soft Touch Post Op2009-02-12
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
Slimline Cast Boot2008-08-20
Ocean Well Footwear Co., Ltd. [OCEAN WELL Co., Ltd.]
Poly Cast Boot, Law Profile Cast Shoe2008-08-20
OCEAN WELL CO., LTD.
Slimline Cast Boot2008-08-20
OCEAN WELL CO., LTD.
Poly Cast Boot, Law Profile Cast Shoe2008-08-20

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091785558Yantian,China (Mainland) -> Long Beach, CaliforniaMEDICAL-SURGICAL SHOE265 CTN
2020091416096Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseySHOES315 CTN
2020082411983Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyFOOTWEAR280 CTN
202007078318Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseySHOES300 CTN
202007066989Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseySHOES300 CTN
2020052515897Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseySHOES335 CTN
2020051115429Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyFOOTWEAR680 CTN
2020042017914Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyFOOTWEAR544 CTN

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