Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003744503

FEI Number

3003744503

Entity Name

MEDISCAN GMBH & CO. KG, STERILISATIONSANLAGE SEIBE

City/State/Country

SEIBERSDORF Niederosterreich, AT

Establishment Address

IM FORSCHUNGSZENTRUM, SEIBERSDORF Niederosterreich A-2444, 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

IODOSORB GEL Sempermed Syntegra UV BEADS, HYDROPHILIC Sempermed Syntegra IR sempermed syntegra preCision Criterion by Henry Schein Patterson Veterinary Pivetal Dealmed Sempermed supreme Vacuette Blood Collection Tubes K2EDTA Realize Adjustable Gastric Band-C Realize Injection Port and Applier Realize Adjusteable Gastric Band Vacuette Blood Collection Tubes K2EDTA Gel Suprasorb A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2015-12-18
MQH	Microtools, Assisted Reproduction (Pipettes)	Obstetrics/Gynecology	Class 2	884.6130	2025-12-16
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2025-12-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2025-12-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2020-07-13
KOZ	Beads, Hydrophilic, For Wound Exudate Absorption	General, Plastic Surgery	Class 1	878.4018	2015-12-18
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2018-07-19
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2009-12-21
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2013-02-18
LTI	Implant, Intragastric For Morbid Obesity	Unknown	Class 3	N/A	2009-12-21
PJE	Blood/Plasma Collection Device For Dna Testing	Clinical Chemistry	Class 2	862.1675	2013-02-18
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2014-02-12

Official Correspondent

No official correspondent registered.

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
9613662	MEDISCAN GMBH & CO. KG	KREMSMUNSTER Oberosterreich, AT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

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3005139112	PERSTORP SPECIALTY CHEMICALS AB, PERSTORP PHARMA	PERSTORP Skane lan [SE-12], SE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003744503. Last updated year: 2026. Please use registration number 3003744503 when referencing this establishment in official correspondence.