KOROT CO., LTD

FDA Device Registration & Listing · Cheonan-si Chungnam, KR · Registration 3027645104

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
3027645104
FEI Number
3027645104
Entity Name
KOROT CO., LTD
City/State/Country
Cheonan-si Chungnam, KR
Establishment Address
1-102, 330, Yeongok-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si Chungnam 31026, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
KOROT Co., Ltd (Owner Number: 10088436)
Owner / Operator Contact Address
54, Nonhyeon-ro 2-gil, Gangnam-gu, Seoul, KR-11 06313, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221764
PMA Number
N/A

All Registered Proprietary Names

KOROT P3 Accurate BPBIO280KV

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

KOROT 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
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

Similar Registrations

Registration Number Establishment Name Location
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3006543075 SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI SHANGHAI, CN
3011912849 BODYTRACE San Jose, CA, US
3036999955 ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL Largo, MD, US
3019575688 AKTIIA SA Neuchatel, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027645104. Last updated year: 2026. Please use registration number 3027645104 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.