Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007582648

FEI Number

3007582648

Entity Name

THEO MANUFACTURING BV

City/State/Country

Maastricht Limburg, NL

Establishment Address

Sleperweg 44, Maastricht Limburg 6222 NK, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THEO MANUFACTURING BV (Owner Number: 10028046)

Owner / Operator Contact Address

Sleperweg 44, Maastricht, NL-LI 6222 NK, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053613

PMA Number

N/A

All Registered Proprietary Names

L-Mesitran Active; L-Mesitran Border; L-Mesitran Hydro; L-Mesitran Net Gentell Honey Hydrogel 2.4 X 2.4; Gentell Honey Hydrogel 4.7 X 3.4; Gentell Honey Hydrogel 7 X 5;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2008-12-24

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

THEO MANUFACTURING BV

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Similar Registrations

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007582648. Last updated year: 2026. Please use registration number 3007582648 when referencing this establishment in official correspondence.