Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616005

FEI Number

3004848623

Entity Name

NIDACON INTERNATIONAL AB

City/State/Country

MOLNDAL Vastra Gotaland, SE

Establishment Address

FLOJELBERGSGATAN 16B, MOLNDAL Vastra Gotaland SE-431 37, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NIDACON INTERNATIONAL AB (Owner Number: 9033529)

Owner / Operator Contact Address

FLOJELBERGSGATAN 16B, --, MOLNDAL, SE-O SE-431 37, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PURESPERM BUFFER-PSB-100 Thermoblast-TBK-010 Vitriblast-VBK-010 ProInsert-PI15-5 NidOil-NO-400 NidOil-NO-100 PureSperm® 100 PureSperm® 100K PureSperm 100-PS100-250 PureSperm 100-PS100-1000K PureSperm 100-PS100-100 SpermCryoProtec-SCP-020 CryoFloater Vial-CFV-001 CryoFloater Straw-CFS-001 PureSperm SpeedKit PureSperm 80-PS80-100 PureSperm 40/80-PSK-020 PureSperm 90-PS90-100 PureSperm SpeedKit-PSSK-010 PureSperm 40-PS40-100 PureSperm 80-PSUL SPERMCATCH PURESPERM WASH-PSW PURESPERM WASH-PSW-100 PURESPERM WASH-PSW-020 SpermVitalStain-SVS-010

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2010-11-08
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2014-02-27
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2016-09-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	1998-07-02
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	1998-07-02
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-14
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2012-12-14
HYB	Eosin Y	Hematology	Class 1	864.1850	2016-09-01

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

NIDACON INTERNATIONAL AB

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
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

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3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616005. Last updated year: 2026. Please use registration number 9616005 when referencing this establishment in official correspondence.