Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027986197

FEI Number

3027986197

Entity Name

SPOL CO., LTD.

City/State/Country

Namdong-gu Incheon, KR

Establishment Address

54-7 , Eumsilseo-ro, Namdong-gu Incheon 21601, KR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device,Foreign Private Label Distributor

Owner / Operator

Spol Co., Ltd. (Owner Number: 10088609)

Owner / Operator Contact Address

54-7 , Eumsilseo-ro, Namdong-gu, KR-28 21601, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Niveus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-08-29

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

Spol 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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027986197. Last updated year: 2026. Please use registration number 3027986197 when referencing this establishment in official correspondence.