Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012422258

FEI Number

3012422258

Entity Name

SG BioScience, INC

City/State/Country

Dongdaemun-gu Seoul, KR

Establishment Address

6-7F, 288, Dapsimni-ro,, Dongdaemun-gu Seoul 02637, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SG BioScience, Inc (Owner Number: 10076886)

Owner / Operator Contact Address

6-7F, 288, Dapsimni-ro, Dongdaemun-gu, KR-11 02637, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AllrangeKit Urine Sample Collection Kit AllrangeKit Oral Swab Collection kit ALLTM Set, GeneTM Set (Transport medium), SELTM Set (Transport medium) AllrangeKit Nasal Swab Collection kit STI-12 Sample Collection and Transport Kit AllrangeKit Urine Sample Collection kit AllrangeKit Nasal Swab Collection kit ALLTM Set, GeneTM Set (Brush), SELTM Set (Brush), SG Brush II AllrangeKit Oral Swab Collection kit AllrangeKit Stool Sample Collection kit AllrangeKit Saliva Sample Collection kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2026-05-27
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2020-08-04
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2024-01-10
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2020-08-04
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-11-14

Official Correspondent

Semoon Oh

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

SG BioScience, Inc

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3027605742	Xiamen Zhiyuan Medical Technology Co., Ltd.	XIAMEN Fujian, CN
2320762	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US
3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3044466317	MEDINOVA GROUP CO.	Laguna Beach, CA, US
1055236	DEROYAL INDUSTRIES, INC.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012422258. Last updated year: 2026. Please use registration number 3012422258 when referencing this establishment in official correspondence.