OCEAN WELL CO., LTD.

FDA Device Registration & Listing · Dongguan Guangdong, CN · Registration 3007125287

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007125287
FEI Number
3007125287
Entity Name
OCEAN WELL CO., LTD.
City/State/Country
Dongguan Guangdong, CN
Establishment Address
Rm. 201, Building 1, No. 38, Baihao Industry St., Houjie Town,, Dongguan City, Guangdong, China, Dongguan Guangdong 523957, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Ocean Well Co., Ltd. (Owner Number: 10026765)
Owner / Operator Contact Address
Rm. 201, Building 1, No. 38, Baihao Industry St., Houjie town,, Dongguan, CN-GD 523955, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ORTHOTIC APPLIANCE- POST OPERATIVE SHOE Protector, skin pressure FQL - STOCKING, MEDICAL SUPPORT (FOR GENERAL MEDICAL PURPOSES)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNP Orthosis, Corrective Shoe Physical Medicine Class 1 890.3475 2009-02-12
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2017-04-12
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2017-08-31

Official Correspondent

James Chang

US Agent Details

Mark Cooper Business: Darco International Inc. Email: mcooper@darcointernational.com Phone: (304) 5224883

Related Public Records

Same Entity

Ocean Well Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007125287. Last updated year: 2026. Please use registration number 3007125287 when referencing this establishment in official correspondence.
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