Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004176951

FEI Number

3004176951

Entity Name

ABENA INTERNATIONAL A/S

City/State/Country

AABENRAA Syddanmark, DK

Establishment Address

EGELUND 35, AABENRAA Syddanmark 6200, DK

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ABENA INTERNATIONAL A/S (Owner Number: 9059287)

Owner / Operator Contact Address

EGELUND 35, --, AABENRAA, DK-NOTA 6200, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Abena Abena Burn Dressing Abena Hydrogel Dressing Curi Med Hydrogel Dressing ABENA Curi-Med Hydrocolloid Wound Dressing Abena Hydrophilic Wound Dressing Calcium Alginate Wound Dressing Abena Xeroform Dressing Abena Petrolatum Dressing Curi Med Foam Dressing Curi Med Petrolatum Dressing Curi Med Oil Dressing Curi Med Xeroform Dressing Abena Oil Dressing Abena Foam Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2014-12-02
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2003-10-23
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2014-12-02
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2014-12-02

Official Correspondent

Nick Morganti

US Agent Details

Nick Morganti Business: Abena North America Email: nmor@abena.com Phone: (310) 4314300

Related Public Records

Same Entity

ABENA INTERNATIONAL A/S

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3009662219	Custom Medical and Safety Products Inc.	Buffalo, NY, US
3038014307	CURAPEP LLC	Burlington, WI, US
3043012215	ZENESIS HOLDINGS CO., LIMITED	Kowloon, HK
3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004176951. Last updated year: 2026. Please use registration number 3004176951 when referencing this establishment in official correspondence.