Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013415761

FEI Number

3013415761

Entity Name

BEDAL International NV

City/State/Country

Diepenbeek Limburg, BE

Establishment Address

Agoralaan A bis, Diepenbeek Limburg 3590, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bedal International NV (Owner Number: 10053494)

Owner / Operator Contact Address

Agoralaan A bis, Diepenbeek, BE-VLI 3590, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bedal-5 Universal, FlexGrip Universal Bedal PICC/CVC, Bedal PIVC, FlexGrip PICC, FlexGRIP Jr PIVC-NEX- Universal-CVC Bedal-3 PIVC Bedal-4 EPI/PNB, FlexGrip EPI/PNB Bedal-1 Drainpatch Bedal Air S,M FlexGRIP Jr. PICC 2.7 -5 Fr FlexGRIP Alpha, FlexGRIP CVC FlexGrip Neo PIVC Umbilical A PICC Bedal Flex XS, Bedal Flex S, Bedal Flex M FlexGRIP Foley

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2019-10-29
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-09
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-04-09

Official Correspondent

Alexander Van Damme

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

Bedal International NV

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013415761. Last updated year: 2026. Please use registration number 3013415761 when referencing this establishment in official correspondence.