Elos Medtech Skara AB

FDA Device Registration & Listing · Skara Vastra Gotaland, SE · Registration 3012416874

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
3012416874
FEI Number
3012416874
Entity Name
Elos Medtech Skara AB
City/State/Country
Skara Vastra Gotaland, SE
Establishment Address
Hasthagsgatan 2, Skara Vastra Gotaland S-532 37, SE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Elos Medtech Skara AB (Owner Number: 10051299)
Owner / Operator Contact Address
Hasthagsgatan 2, Skara, SE-O S-53237, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ICSI Dish Centre Well Dish Culture Dish 40 mm 5 Well Culture Dish Micro Droplet Culture Dish Micro Well Group Culture Dish, 16-well Micro Well Group Culture Dish,9-well Micro Well Group Culture Dish,16-well

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2016-03-02
MQK Labware, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6160 2016-03-01

Official Correspondent

Maria Skold

US Agent Details

JODIE GILMORE Business: ONYX MEDICAL CORPORATION Email: jodie.gilmore@elosmedtech.com Phone: (901) 3236699

Related Public Records

Same Entity

Elos Medtech Skara AB
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012416874. Last updated year: 2026. Please use registration number 3012416874 when referencing this establishment in official correspondence.
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