Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9610569

FEI Number

3002806287

Entity Name

MIKROLAB STOCKHOLM AB

City/State/Country

Sollentuna Stockholm, SE

Establishment Address

Kung Hans Vag 3, Sollentuna Stockholm 19268, SE

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Mikrolab Stockholm AB (Owner Number: 10087767)

Owner / Operator Contact Address

Kung Hans Vag 3, Sollentuna, SE-AB 19268, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Patellar Epiguide Patellar Epidummy Patellar Epimandrel Femoral Epidummy Femoral Drilling Socket Femoral Adjustment Socket Patellar Adjustment Socket Femoral Epimandrel Femoral Epiguide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3540	2023-04-06

Official Correspondent

Marina Lundin

US Agent Details

Patrick Jamnik Email: patrick.jamnik@episurf.com Phone: (214) 9836156

Related Public Records

Same Entity

Mikrolab Stockholm AB

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 9610569. Last updated year: 2026. Please use registration number 9610569 when referencing this establishment in official correspondence.