KOGA ISOTOPE LTD.

FDA Device Registration & Listing · Koka-shi Shiga, JP · Registration 3002807408

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
3002807408
FEI Number
3002807408
Entity Name
KOGA ISOTOPE LTD.
City/State/Country
Koka-shi Shiga, JP
Establishment Address
53-6 Jinbo,Koka-cho, Koka-shi Shiga 520-3404, JP
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer)
Owner / Operator
KOGA ISOTOPE LTD. (Owner Number: 10025197)
Owner / Operator Contact Address
53-6 Jinbo,Koka-cho, Koka-shi, JP-25 520-3404, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PuraStat BD Vacutainer Rapid Serum Tube Accu-Chek Safe-T-Pro Plus Lancing Device Assure Lance Plus Capiject Safety Lancet OneTouch Delica Safety HemoCue Safety Lancet Assure Lance Heel Lancet Newborn Vitri Plate, Warm Plate Accu-Chek Softclix Cryotec (10 pieces) (Blue) BD Vacutainer REXEED SERIES DIALYZERS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QAU Hemostatic Device For Endoscopic Gastrointestinal Use General, Plastic Surgery Class 2 878.4456 2025-01-24
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-12-13
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-12-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2017-06-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2017-06-15
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-12-08
PUD Labware, Assisted Reproduction, Exempt Obstetrics/Gynecology Class 2 884.6160 2019-12-09
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature General, Plastic Surgery Class 2 878.4850 2023-12-08
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-03-04
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-03-04
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2019-11-27
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2016-12-13
MSF Hemodialyzer, Re-Use, High Flux Gastroenterology, Urology Class 2 876.5860 2013-07-24
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2013-07-24

Official Correspondent

No official correspondent registered.

US Agent Details

Kristi Smedley Business: Center for Regulatory Services, Inc. Email: Smedley@cfr-services.com Phone: (703) 7867674

Related Public Records

Same Entity

KOGA ISOTOPE 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
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K130132 Medipurpose Pte. , Ltd. BABYLANCE HEEL INCISION DEVICE 2013-02-11
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2025 Wilson-Cook Medical Inc. 2
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0044-2008 Becton Dickinson & Company 2
Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0019-2025 Outset Medical, Inc. 2
Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility.
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807408. Last updated year: 2026. Please use registration number 3002807408 when referencing this establishment in official correspondence.
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