Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012637967

FEI Number

3012637967

Entity Name

SPARMED APS

City/State/Country

Farum Hovedstaden, DK

Establishment Address

Ryttermarken 2, Farum Hovedstaden 3520, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SparMed ApS (Owner Number: 10055832)

Owner / Operator Contact Address

Ryttermarken 2, Farum, DK-NOTA 3520, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oosafe Dishes ICSIPullator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2017-10-11
MQJ	Micromanipulators And Microinjectors, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6150	2017-10-11

Official Correspondent

Susan Bush

US Agent Details

Donald J Luongo Business: Astec Bio USA, Inc. Email: oosafe-support@astec-bio.com Phone: (781) 7490734

Related Public Records

Same Entity

SparMed ApS

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012637967. Last updated year: 2026. Please use registration number 3012637967 when referencing this establishment in official correspondence.