Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613662

FEI Number

3002919051

Entity Name

MEDISCAN GMBH & CO. KG

City/State/Country

KREMSMUNSTER Oberosterreich, AT

Establishment Address

BAD HALLER STRASSE 34, KREMSMUNSTER Oberosterreich A-4550, AT

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

MEDISCAN GMBH & CO. KG (Owner Number: 9033053)

Owner / Operator Contact Address

BAD HALLER STRASSE 34, --, KREMSMUNSTER, AT-4 A-4550, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SpeediCath Flex Coude VACUETTE® SAFELINK Holder with male luer lock Vacuette Blood Collection Tubes K2EDTA Gel Vacuette Blood Collection Tubes FX Sodium Fluoride / K3 EDTA Vacuette Blood Collection Tubes FX Sodium Fluoride / Potassium Oxalate Luja female VACUETTE Urine CCM Tube VACUETTE Urine Count and Culture, Manitol Tube Plastic Cannula Holdex MiniCollect Carrier Tubes Vacuette Urine Tube MiniCollect Funnel Vacuette Urine Transfer Device Vacuette No-Additive Tubes MiniCollect No-Additive Tubes Vacuette Urine Beaker with Integrated Transfer Device SpeediCath Compact female/female plus SpeediCath Soft VACUETTE® EVOPROTECT SAFETY Blood Collection Set + Luer Adapter 21Gx3/4" VACUETTE® EVOPROTECT SAFETY Blood Collection/Infusion Set 21Gx3/4" VACUETTE® EVOPROTECT SAFETY Blood Collection Set + Holder 21Gx3/4" ECHELON ENDOPATH Staple Line Reinforcement HOLDEX Single-Use Holder PP, single-packed Premium One Implant Systems SpeediCath Flex Set Vacuette Blood Collection Tube with Clot Activator Vacuette Blood Collection Tubes with Clot Activator and Gel Patterson Veterinary Pivetal Dealmed Sempermed supreme Geri dish SpeediCath Compact Set Female Vacuette Blood Collection Tubes 4NC ESR sodium citrate 3.2% Vacuette QuickShield Complete Safety Tube Holder Prama White Implant Systems Vacuette Blood Collection Tubes K3EDTA Luja Coude Vacuette Blood Collection Tubes K2EDTA SpeediCath Compact Set Male Vacuette Blood Collection Tubes Trace Elements Sodium Heparin Vacuette Blood Collection Tubes Lithium Heparin Sep Premium Shelta Implant Systems Cellmaster Cell Culture Roller Bottles Cellstar Cell Culture Flasks Cellstar Cell Culture Tubes Holdex Single-Use Holder PP, Single-packed SpeediCath Compact Male kit esolution Esophageal Retractor Vacuette Blood Collection Tubes No Additive

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2018-11-14
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2013-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-02-24
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2017-03-23
LIO	Device, Specimen Collection	Microbiology	Class 1	866.2900	2017-03-23
FGY	Cannula, Injection	General, Plastic Surgery	Class 1	878.4200	2013-11-20
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	2013-11-20
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2026-02-24
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-27
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2022-11-24
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-02-18
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-20
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2009-12-21
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-12-21
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2018-01-31
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
GIM	Tubes, Vacuum Sample, With Anticoagulant	Clinical Chemistry	Class 2	862.1675	2013-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
GHC	Tube, Sedimentation Rate	Hematology	Class 1	864.6700	2013-02-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-02-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-20
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2024-07-02
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2024-07-02
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
GBM	Catheter, Urethral	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2009-12-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-20
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2013-11-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2017-01-11
EZD	Catheter, Straight	Gastroenterology, Urology	Class 2	876.5130	2022-11-30
QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation	Cardiovascular	Class 2	870.5710	2025-01-30
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2009-12-21

Official Correspondent

MARKUS NIEDERREITER

US Agent Details

Angela Drysdale Business: GREINER BIO-ONE NORTH AMERICA, INC. Email: angela.drysdale@gbo.com Phone: (303) 3243201

Related Public Records

Same Entity

MEDISCAN GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003744503	MEDISCAN GMBH & CO. KG, STERILISATIONSANLAGE SEIBE	SEIBERSDORF Niederosterreich, AT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18
K003761	Medical Packaging Corp.	NAT - NUCLEIC ACID TRANSPORT	2001-05-31
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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-0004-2013	Cure Medical LLC	2	Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539 The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder.
Z-0019-2023	Hobbs Medical, Inc.	1	Hobbs Scope Introducer Catalog Number: 4650
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613662. Last updated year: 2026. Please use registration number 9613662 when referencing this establishment in official correspondence.