Occlutech GmbH

FDA Device Registration & Listing · Jena Thuringia, DE · Registration 3014616394

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
3014616394
FEI Number
3014616394
Entity Name
Occlutech GmbH
City/State/Country
Jena Thuringia, DE
Establishment Address
Winzerlaer Strasse 2, Jena Thuringia 07745, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,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
3012613541 Occlutech International AB Helsingborg Skane, SE

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
9617429 MEDICOPLAST INTERNATIONAL GMBH ILLINGEN Saarland, DE
3012613541 Occlutech International AB Helsingborg Skane, SE
3031365458 WOMED SAS Montpellier Herault, FR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014616394. Last updated year: 2026. Please use registration number 3014616394 when referencing this establishment in official correspondence.
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