Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013944123

FEI Number

3013944123

Entity Name

Eurofins Infinity Laboratory Group Inc.

City/State/Country

San Jose, CA, US

Establishment Address

1836 Stone Ave, San Jose, CA 95125, US

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Eurofins - Infinity Laboratory Group Inc. (Owner Number: 10080298)

Owner / Operator Contact Address

1836 Stone Ave, San Jose, CA 95125, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Device, Monitoring, intracranial pressure Shunt, central nervous system and components EagleRay, MantaRay, and StingRay families endoscopic access overtube, gastroenterology-urology RhinAer Stylus-CAT821 ETN, GXH - PACIRA Cervical/Lumbar Device M6 Product Family - Spinal Kinetics (Orthofix) PureForm-Surgiform Royal Biologics IOVERA Device Neurovascular embolization Artio Medical Silicone-Surgiform CellFX Percutaneous Electrode - Pulse Vivaer Stylus-CAT723 Electrosurgical, cutting & coagulation & accessories Platelet And Plasma Separator For Bone Graft Handling IRRAS MAKO 7 Procept BioRobotics-HYDROS Robotic system, Handpiece & TRUS Probe Urocross Expander System - Prodeon Medical Catheter, Angioplasty, peripheral, transluminal Catheter, angioplasty, peripheral,transluminal Lucid Diagnostics KAI MEDTECH LLC Silicone-Surgiform InSeca ARC Stylus CAT409 Arthroscope MIDAScope And Introducer Kit, And MidaSystem Sniper Infusion Catheter with Ballon Occlusion CarpX-PAVmed Intravascular Catheter - Provisio Vivaer ARC Stylus-CAT410 IRRAflow Catheter, IRRAflow tube set, IRRAflow Control Unit T-Stat Ischemia Monitor and sensors Bolt Navigation Case 1919-DWG-400 - CIRCINUS MEDICAL TECHNOLOGY, LLC PolarCath Peripheral Dilatation system Neptune-Pathfinder Endoscope Overtube Balloon Pathfinder Endoscope Overtube Gen 2 - Neptune medical Prodeon Urethral Sheath System - Prodeon Medical Suction Adaptor - Neptune Medical SFAM-Surgiform FLASH Flex Aorto-Ostial Angioplasty System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2021-01-25
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2021-01-25
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-01-25
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2021-09-07
ETN	Stimulator, Nerve	Ear, Nose, Throat	Class 2	874.1820	2021-09-07
MJO	Prosthesis, Intervertebral Disc	Unknown	Class 3	N/A	2022-12-29
FWP	Prosthesis, Chin, Internal	General, Plastic Surgery	Class 2	878.3550	2021-01-25
LZK	Implant, Malar	General, Plastic Surgery	Class 2	878.3550	2021-01-25
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2022-06-27
GXH	Device, Surgical, Cryogenic	Neurology	Class 2	882.4250	2021-01-25
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2021-01-25
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2021-01-25
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-04-06
LZK	Implant, Malar	General, Plastic Surgery	Class 2	878.3550	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-02-05
ORG	Platelet And Plasma Separator For Bone Graft Handling	Hematology	Class 2	864.9245	2021-05-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2022-06-27
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2022-06-27
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2021-01-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-08-21
PZP	Fluid Jet Removal System	General, Plastic Surgery	Class 2	876.4350	2024-08-21
QKA	Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5510	2026-04-02
NTE	Temporary Carotid Catheter For Embolic Capture	Cardiovascular	Class 2	870.1250	2021-01-25
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2021-01-25
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2022-06-27
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2022-06-28
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-06-28
LZK	Implant, Malar	General, Plastic Surgery	Class 2	878.3550	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2021-02-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-02-05
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2021-01-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2026-04-02
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2026-04-02
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-04-02
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2026-04-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2021-02-05
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2021-02-05
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2021-01-25
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-12-13
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2021-01-25
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-11-27
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-03-16
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-04-02
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-02-19
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-02-19
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	General, Plastic Surgery	Class 2	878.3500	2021-01-25
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2026-05-07

Official Correspondent

Jennifer Eagan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eurofins - Infinity Laboratory Group Inc.

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
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013944123. Last updated year: 2026. Please use registration number 3013944123 when referencing this establishment in official correspondence.