ASP Global Manufacturing GmbH

FDA Device Registration & Listing · SCHAFFHAUSEN, CH · Registration 3015392401

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
3015392401
FEI Number
3015392401
Entity Name
ASP Global Manufacturing GmbH
City/State/Country
SCHAFFHAUSEN, CH
Establishment Address
Im Majorenacker 10, SCHAFFHAUSEN 8207, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Advanced Sterilization Products (Owner Number: 9068155)
Owner / Operator Contact Address
33 Technology Drive, --, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K042116
PMA Number
N/A

All Registered Proprietary Names

Tyvek Pouch/Roll with STERRAD Chemical Indicator (123XX, 124XX, 125XX) Cidex OPA (20390) CIDEX OPA Concentrate STERRAD 100NX Sterilizer and Cassette (10104, 10104-002, 10144) STERRAD NX System w ALLClear Technology (10133, 10033ACSW, 10033-004) STERRAD 100S Sterilizer and Cassette (10101, 10113) STERRAD 100S Sterilizer and Cassette (10101, 10113) BIOTRACE Instant Read Steam PCD (73140) BIOTRACE VERISURE and SEALSURE Indicators and Readers STERRAD NX and 100NX with DTI Connectivity (DTINX, DTI100NX) STERRAD 100NX w ALLClear Technology (10144, 10104ACSW, 10104-005,-006,-007,-008) CIDEX OPA Test Strips (2920, 2927, 20392, 20393) AEROFLEX AER, AUTOSURE MRC Reagent, AEROZYME and AERO-OPA (28000, 23300, 25520, 25410) BIOTRACE Instant Read BI (73110) BIOTRACE Instant Read Reader (73430) VERISURE CI Strip (73250) VERISURE CI Strip (73260) VERISURE CI Strip (73350) STERRAD NX Cassette (10133)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2017-08-21
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2017-08-21
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2008-01-10
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2008-01-10
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2008-01-10
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2016-10-31
FLF Sterilizer, Ethylene-Oxide Gas General Hospital Class 2 880.6860 2008-05-06
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-02-06
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 1999-07-08
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2026-04-16
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-10-28
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2024-10-28
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2015-04-08
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 2016-10-31
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2009-05-08
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-02-18
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2019-05-07
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2019-05-07
MED Sterilant, Medical Devices General Hospital Class 2 880.6885 2019-05-07
QVB Biological Sterilization Indicator With Indirect Growth Detection General Hospital Class 2 880.2806 2026-04-16
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2026-04-16
QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator General Hospital Class 2 880.2800 2026-04-16
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2025-02-18
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-02-18
MLR Sterilizer, Chemical General Hospital Class 2 880.6860 1999-07-08

Official Correspondent

Brent Lewis

US Agent Details

Brent Lewis Business: ADVANCED STERILIZATION PRODUCTS Email: brent.lewis@asp.com Phone: (425) 2177539

Related Public Records

Same Entity

Advanced Sterilization Products
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2084725 ADVANCED STERILIZATION PRODUCTS Irvine, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243425 Talladium España, SL Guided DAS Surgical Kit 2025-07-22
K213209 K1 Medical, LLC EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device 2021-12-28
K012105 Symmetry Medical, Inc. POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM 2002-08-02
K243317 Infinitum Eta, Ltd. NUVENTUS NV.C™ Surgical Cassette and Tray 2025-02-11
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2014 Advanced Sterilization Products 2
STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0044-2014 Advanced Sterilization Products 2
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0022-2013 3M Company Health Care Business 3M Center 2
3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015392401. Last updated year: 2026. Please use registration number 3015392401 when referencing this establishment in official correspondence.
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