Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020733550

FEI Number

3020733550

Entity Name

SIRIUS MEDICAL SYSTEMS B.V.

City/State/Country

Eindhoven Noord-Brabant, NL

Establishment Address

High Tech Campus 41, Eindhoven Noord-Brabant 5656AE, NL

Establishment Type(s)

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

Owner / Operator

Sirius Medical Systems B.V. (Owner Number: 10082996)

Owner / Operator Contact Address

High Tech Campus 41, Eindhoven, NL-NB 5656AE, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223682

PMA Number

N/A

All Registered Proprietary Names

Sirius Pintuition Seed 12cm Sirius Pintuition Base Unit Sirius Pintuition Seed 7cm Sirius Pintuition Slim Test Kit Sirius Pintuition Slim Probe Sirius Pintuition Probe Sirius Pintuition Test Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PBY	Temporary Tissue Marker	General, Plastic Surgery	Class 2	878.4300	2023-11-15
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2023-11-15

Official Correspondent

Bram Schermers

US Agent Details

Dana Troup Email: dana.troup@sirius-medical.com Phone: (317) 5015238

Related Public Records

Same Entity

Sirius Medical Systems B.V.

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 3020733550. Last updated year: 2026. Please use registration number 3020733550 when referencing this establishment in official correspondence.