SUN PLATECH CO., LTD.

FDA Device Registration & Listing · Bucheon Gyeonggi, KR · Registration 3001595761

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
3001595761
FEI Number
3001595761
Entity Name
SUN PLATECH CO., LTD.
City/State/Country
Bucheon Gyeonggi, KR
Establishment Address
22-14, saneop-ro, 8beon-gil, Bucheon Gyeonggi 14441, KR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
Sun Platech Co., Ltd. (Owner Number: 10050872)
Owner / Operator Contact Address
103-101 Bucheon Techno Park, Samjeong Dong, Ojeong Gu, Bucheon, KR-41 14501, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HEMODROP BMP Cytology Funnel METAL CYTOLOGY FUNNEL CLIP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KET Filters, Cell Collection, Tissue Processing Pathology Class 1 864.3010 2016-06-07

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

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

Similar Registrations

Registration Number Establishment Name Location
3013548489 ADVANCE SENTRY CORPORATION Markham Ontario, CA
3011781201 GUANGZHOU KOMASPEC MECHANICAL AND ELECTRICAL PRODUCTS MANUFA Huashan Town, Huadu District, Guangdong, CN
3010692993 DIAPATH S.P.A. Martinengo Bergamo, IT
1220477 ISOMEDIX OPERATIONS INC. Northborough, MA, US
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001595761. Last updated year: 2026. Please use registration number 3001595761 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.