Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011108368

FEI Number

3011108368

Entity Name

GENERAL BIO CO., LTD.

City/State/Country

Namwon Jeonbuk, KR

Establishment Address

254, Yongtusan-ro, Songdong-myeon, Namwon Jeonbuk 55793, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

General Bio Co., Ltd. (Owner Number: 10058516)

Owner / Operator Contact Address

254, Yongtusan-ro, Songdong-myeon, Namwon, KR-45 55793, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CareCellve TERA Patch GCOOP LAPY V CareCellve Wave Plus IN-5600 GCOOP Mechanic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2025-06-03
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2022-03-30
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-08-21

Official Correspondent

Mi-Seon So

US Agent Details

Jisuk Kim Business: GCOOP USA CORP. Email: jkim@jkbios.com Phone: (213) 7602878

Related Public Records

Same Entity

General Bio 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 3011108368. Last updated year: 2026. Please use registration number 3011108368 when referencing this establishment in official correspondence.