Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042175767

FEI Number

3042175767

Entity Name

PROSTEM HAIR B.V.

City/State/Country

Maastricht Limburg, NL

Establishment Address

Chateau Jerusalem, Jeruzalemweg 2, Maastricht Limburg 6222 NG, NL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ProStem Hair B.V. (Owner Number: 10094257)

Owner / Operator Contact Address

Chateau Jerusalem, Jeruzalemweg 2, Maastricht, NL-LI 6222 NG, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FolliGem HST Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2025-11-20

Official Correspondent

Coen Gho

US Agent Details

Ryan Kruchten Business: RookQS Email: ryan.kruchten@rookqs.com Phone: (770) 8330116

Related Public Records

Same Entity

ProStem Hair B.V.

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
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12
K861867	Hazleton Research Products, Inc.	MEM ALPHA EAGLE MEDIUM	1986-05-29
K821916	Dutchland Laboratories, Inc.	IMPROVED MEM-RICHTER'S POWDER MODIF.	1982-07-27
K810767	Dutchland Laboratories, Inc.	RPMI 1640 MEDIUM	1981-05-08

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3008496303	REGEN LAB Sa	LE MONT-SUR-LAUSANNE Vaud, CH
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042175767. Last updated year: 2026. Please use registration number 3042175767 when referencing this establishment in official correspondence.