ORTHOTECH CO., LTD.

FDA Device Registration & Listing · Dong-Gu Daegu, KR · Registration 3042205143

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
3042205143
FEI Number
3042205143
Entity Name
ORTHOTECH CO., LTD.
City/State/Country
Dong-Gu Daegu, KR
Establishment Address
100-4, Cheombok-ro, Dong-Gu Daegu 41061, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ORTHOTECH Co., Ltd. (Owner Number: 10094495)
Owner / Operator Contact Address
100-4, Cheombok-ro, Dong-gu, KR-27 41061, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

BA0103.75A BA0104.75A BA0102.75A BA0101.75A rev.D Carragel S rev.D Carragel rev.D Carragel T

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HGD Applicator, Vaginal Obstetrics/Gynecology Class 1 884.4520 2025-12-03
NAE Dressing, Wound, Hydrogel Without Drug And/Or Biologic General, Plastic Surgery Class 1 878.4022 2025-12-03

Official Correspondent

Ilhwan Kim

US Agent Details

chuljoo jeon Business: KTR Americas Inc. Email: americas@ktr.or.kr Phone: (562) 3172865

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3014462004 INGE SPA Garbagnate Milanese Milano, IT
3017458128 Seed Health Inc New York, NY, US
3019039128 B&A PRECISION SILICONE RUBBER (DONGGUAN) CO., LTD Dongguan Guangdong, CN
3024676893 PANGAEA TECHNOLOGIES LLC The Woodlands, TX, US
3017425145 Organon LLC Jersey City, NJ, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042205143. Last updated year: 2026. Please use registration number 3042205143 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.