Occlutech International AB

FDA Device Registration & Listing · Helsingborg Skane, SE · Registration 3012613541

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
3012613541
FEI Number
3012613541
Entity Name
Occlutech International AB
City/State/Country
Helsingborg Skane, SE
Establishment Address
Landskronavagen 2, Helsingborg Skane 25232, SE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Occlutech Holding AG (Owner Number: 10084004)
Owner / Operator Contact Address
Feldstrasse 22, Schaffhausen, CH-SH 8200, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P200032

All Registered Proprietary Names

Occlutech ASD Occluder and Occlutech Pistol Pusher

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OZG Transcatheter Septal Occluder (Atrial) Unknown Class 3 N/A 2024-01-17

Official Correspondent

No official correspondent registered.

US Agent Details

Christine Lee Business: OCCLUTECH US LLC Email: christine.lee@occlutech.com Phone: (404) 4227739

Related Public Records

Same Entity

Occlutech Holding AG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012290852 Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti Bakirkoy Istanbul, TR
3014616394 Occlutech GmbH Jena Thuringia, DE

Similar Registrations

Registration Number Establishment Name Location
3017907716 SET MEDIKAL SANAYI VE TICARET ANONIM SIRKETI esenyurt Istanbul, TR
3012290852 Occlutech Tibbi Urunler San.ve Tic. Ltd. Sti Bakirkoy Istanbul, TR
3014616394 Occlutech GmbH Jena Thuringia, DE
9617429 MEDICOPLAST INTERNATIONAL GMBH ILLINGEN Saarland, DE
3031365458 WOMED SAS Montpellier Herault, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012613541. Last updated year: 2026. Please use registration number 3012613541 when referencing this establishment in official correspondence.
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