Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030398124

FEI Number

3030398124

Entity Name

FURINE APS

City/State/Country

Skaevinge Hovedstaden, DK

Establishment Address

Industrivaenget 1, Skaevinge Hovedstaden 3320, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Furine ApS (Owner Number: 10090994)

Owner / Operator Contact Address

Industrivaenget 1, Skaevinge, DK-84 3320, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Furine Collect Furine plus Furine Furine Small

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FON	Bag, Drainage, With Adhesive, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-06-21
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2024-06-12

Official Correspondent

Helene Hjenner

US Agent Details

Bob Duffy Email: Bob.duffy@mdpps-inc.com Phone: (858) 4871859

Related Public Records

Same Entity

Furine ApS

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-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

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3019865496	Dongguan Kangda Medical Technology Co., Ltd	Dongguan Guangdong, CN
3012002722	PRO-MED (WUXI)IMP.& EXP.CO.,LTD.	Wuxi Jiangsu, CN
3010198795	Shanghai Joy Crown Industry Co., Ltd	Pu Dong New Area Shanghai, CN
3014351477	STIEHL TECH	Lisle, IL, US
3005621808	ANJI HONGDE MEDICAL PRODUCTS CO., LTD.	HUZHOU Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030398124. Last updated year: 2026. Please use registration number 3030398124 when referencing this establishment in official correspondence.