Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008388260

FEI Number

3008388260

Entity Name

UNITRON GROUP BV

City/State/Country

IJzendijke Zeeland, NL

Establishment Address

Schansestraat 7, IJzendijke Zeeland 4515 RN, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Unitron Group BV (Owner Number: 10032425)

Owner / Operator Contact Address

Schansestraat 7, IJzendijke, NL-ZE 4515 RN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thermaprep 2 Obturator Oven GT Obturator Obturator Oven Thermaprep Plus Obturator Oven Guttamaster Obturator Oven GT Series X Obturator Oven Profile Vortex Obturator Oven Protaper Universal Obturator Oven Comfort Marker Lunoa SPT Inca

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	2010-05-12
QRN	Radiation Therapy Marking Device	Radiology	Class 2	892.5785	2022-03-04
MYB	Pillow, Cervical (For Mild Sleep Apnea)	Dental	Class 2	872.5570	2018-11-05
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2010-05-12
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2010-05-12
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2010-05-12

Official Correspondent

Manon de Koeijer

US Agent Details

Mindy McCann Business: Qserve Group US Inc Email: USagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Unitron Group 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
K100160	Sleep Specialists, LLC	ZZOMA POSITIONAL SLEEPER MODEL 001	2010-05-11
K180608	Nightbalance BV	Lunoa System	2018-06-05
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008388260. Last updated year: 2026. Please use registration number 3008388260 when referencing this establishment in official correspondence.