Lagis Enterprise Co., Ltd.

FDA Device Registration & Listing · Dajia Dist, Taichung City, TW · Registration 3007185043

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
3007185043
FEI Number
3007185043
Entity Name
Lagis Enterprise Co., Ltd.
City/State/Country
Dajia Dist, Taichung City, TW
Establishment Address
No. 29, Gong 1st Rd, Dajia Dist, Taichung City 437, TW
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Lagis Enterprise Co., Ltd (Owner Number: 10029993)
Owner / Operator Contact Address
No. 29, Gong 1st Rd,, Dajia Dist, TW-TXG 437, TW
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253134
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2026-06-09

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

Lagis Enterprise 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
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007185043. Last updated year: 2026. Please use registration number 3007185043 when referencing this establishment in official correspondence.
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