ISLAND POLYMER INDUSTRIES-GMBH

FDA Device Registration & Listing · BITTERFELD-WOLFEN Saxony-Anhalt, DE · Registration 3004775917

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
3004775917
FEI Number
3004775917
Entity Name
ISLAND POLYMER INDUSTRIES-GMBH
City/State/Country
BITTERFELD-WOLFEN Saxony-Anhalt, DE
Establishment Address
ANDRESENSTRASSE 6, BITTERFELD-WOLFEN Saxony-Anhalt 06766, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IGE Medical Devices, LLC (Owner Number: 10052984)
Owner / Operator Contact Address
267 E. Jericho Tpke, Mineola, NY 11501, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IPI-Pathotape IPI Pathomat IPI-PATHOCUT IPI PATHOSLIDE IPI Pathoslide 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KES Coverslips, Microscope Slide Pathology Class 1 864.3010 2016-10-21
KIM Device For Sealing Microsections Pathology Class 1 864.3400 2022-02-04

Official Correspondent

Robert Massey

US Agent Details

Robert Massey Business: IGE-Medical Devices, LLC Email: massey@islandgroup.com Phone: (516) 7462100

Related Public Records

Same Entity

IGE Medical Devices, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0019-2019 Leica Microsystems, Inc. 1
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.

Similar Registrations

Registration Number Establishment Name Location
3011676045 HAIMEN SHENGBANG LABORATORY EQUIPMENT CO., LTD Haimen Jiangsu, CN
2244900 GLOBE SCIENTIFIC, LLC Mahwah, NJ, US
3006554788 JIANGSU HUADONG MEDICAL DEVICE INDUSTRY CO., LTD. YANGZHOU CITY, Jiangsu, CN
3003965134 RECE INTERNATIONAL CORP. Miami Lakes, FL, US
3005271071 BIOMED PLASTICS CO. TAICANG, JIANGSU, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004775917. Last updated year: 2026. Please use registration number 3004775917 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.