Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032611331

FEI Number

3032611331

Entity Name

CALEB CO., LTD.

City/State/Country

Won-Ju-Si Gangwon, KR

Establishment Address

105-5 Cheongryongsaemmal-gil, Sillim-myeon, Won-Ju-Si Gangwon 26458, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CALEB CO., LTD. (Owner Number: 10094003)

Owner / Operator Contact Address

105-5 Cheongryongsaemmal-gil, Sillim-myeon, Won-Ju-Si, KR-42 26458, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Single Use Pulse Lavage (E-5, E-7, E-21)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2025-09-08

Official Correspondent

Gyeong-Gil Yoo

US Agent Details

chuljoo jeon Business: KTR Americas Inc. Email: americas@ktr.or.kr Phone: (562) 3173586

Related Public Records

Same Entity

CALEB CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23

Similar Registrations

Registration Number	Establishment Name	Location
3012964172	ELITE MEDTEK(JIANGSU) CO., LTD	Changzhou City Jiangsu, CN
3009217531	Eurofins STERIPAC GMBH	Calw-Altburg Baden-Wurttemberg, DE
1718850	LivaNova USA, INC.	ARVADA, CO, US
3045076544	BEIJING YUEWEI MEDICAL TECHNOLOGY CO., LTD	Beijing, CN
9617429	MEDICOPLAST INTERNATIONAL GMBH	ILLINGEN Saarland, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032611331. Last updated year: 2026. Please use registration number 3032611331 when referencing this establishment in official correspondence.