SEAWON MEDITECH CO., LTD.

FDA Device Registration & Listing · Bucheon-si Gyeonggi, KR · Registration 3008770707

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
3008770707
FEI Number
3008770707
Entity Name
SEAWON MEDITECH CO., LTD.
City/State/Country
Bucheon-si Gyeonggi, KR
Establishment Address
33, Bucheon-ro 298beon-gil, Wonmi-gu, Bucheon-si Gyeonggi 14487, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Seawon Meditech Co., Ltd. (Owner Number: 10034631)
Owner / Operator Contact Address
33, Bucheon-ro 298beon-gil, Wonmi-gu, Bucheon-si, KR-41 14487, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Blue Pecker Plus (SWVP-13H11A) SPASY (SWVP-13A) JOIMAX (JMSWSNT) Blue Pecker Plus (SWVP-11H11A) Blue Pecker Plus (SWVP-13H11) SPASY (SWVP-11S) SPASY (SWMVP) SPASY (SWVP-11A) JOIMAX (JMSWSNT23) JOIMAX (JMSWSNT20) JOIMAX (JMSWSNS) Blue Pecker Plus (SWVP-11H11) MIXMAX (SWMX-CMS-01) MIXMAX (SWMX-CMS-02) JOIMAX (JMSWM-1) SPASY (SWM-1) JOIMAX (JMSWM-2) JOIMAX (JMSWM-2T) SPASY (SWM-2) JOIMAX (JMSWM-5) SPASY (SWDG-4A) JOIMAX (JMSWM-4) JOIMAX (CS6601-07) SPASY (SWM-4) JOIMAX (JMSWVEAS) JOIMAX (JMPP0130BF) SPASY (SWM-3) JOIMAX (JMSWM-3) COLEX (SWBMN15N15) COLEX (SWBMN08N15) COLEX (SWBMN11N15) COLEX (SWBMN15H11) COLEX (SWBMN15H15) COLEX (SWBMN15N11) COLEX (SWBMN11H11) COLEX (SWBMN13H11) COLEX (SWBMN11H15) COLEX (SWBMN11N11)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2010-12-17
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2023-09-14
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2010-12-17
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2010-12-17
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2010-12-17
HTW Bit, Drill Orthopedic Class 1 888.4540 2010-12-17
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2019-08-27

Official Correspondent

Chang Yong Kim

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

Seawon Meditech 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
K863293 Lifestream Int'L, Inc. DISPOSABLE SUCTION CANNULA NO. 902008-000 1986-09-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2011 Medical Device Technologies, Inc. 1
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008770707. Last updated year: 2026. Please use registration number 3008770707 when referencing this establishment in official correspondence.
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