Enraf Nonius B V

FDA Filings

This page includes the latest FDA filings for Enraf Nonius B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9612147
• FEI Number: 3002806913
• Name: ENRAF-NONIUS B.V.
• Owner & Operator: NEW COMPANY INVESTMENTS B.V.
• Contact Address: VARESEWEG 127 P.O.Box 12080, 3004 GB; ROTTERDAM NL-NOTA NL-3047AT NL
• Official Correspondent:
  • Anne-Marie VAN MAURIK
  • 31-10-2030680-x
• US Agent:
  • Lee Grasseschi
  • Accelerated Care Plus
  • 775 3361827
  • lgrasseschi@hanger.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 127, VARESEWEG -; ROTTERDAM Zuid-Holland, NL-3047 AT NL
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 08809308380782 Enraf-Nonius B.V.	Compact-II	2025-10-01
GUDID 08720618311177 Enraf-Nonius B.V.	Curapuls 670	2025-10-01
GUDID 08720618311221 Enraf-Nonius B.V.	Sonopuls 190	2025-02-19
GUDID 08720618311153 Enraf-Nonius B.V.	Endolaser 120	2025-02-19
GUDID 08720618311139 Enraf-Nonius B.V.	Sonopuls 494	2025-02-19
GUDID 08720618311108 Enraf-Nonius B.V.	Sonopuls 190	2025-02-19
GUDID 08719992508327 Enraf-Nonius B.V.	EN-Dynamic Rotator	2025-02-19
GUDID 08719992508310 Enraf-Nonius B.V.	EN-Dynamic Squat	2025-02-19
GUDID 08719992508303 Enraf-Nonius B.V.	EN-Dynamic Triceps Dips	2025-02-19
GUDID 08719992508297 Enraf-Nonius B.V.	EN-Dynamic Seated Leg Press	2025-02-19
GUDID 08719992508280 Enraf-Nonius B.V.	EN-Dynamic Seated Leg Curl	2025-02-19
GUDID 08719992508273 Enraf-Nonius B.V.	EN-Dynamic Total Hip	2025-02-19
GUDID 08719992508266 Enraf-Nonius B.V.	EN-Dynamic Fly	2025-02-19
GUDID 08719992508259 Enraf-Nonius B.V.	EN-Dynamic Abduction	2025-02-19
GUDID 08719992508242 Enraf-Nonius B.V.	EN-Dynamic Adduction	2025-02-19
GUDID 08719992508235 Enraf-Nonius B.V.	EN-Dynamic Shoulder Press	2025-02-19
GUDID 08719992508228 Enraf-Nonius B.V.	EN-Dynamic Rowing	2025-02-19
GUDID 08719992508211 Enraf-Nonius B.V.	EN-Dynamic Leg Extension	2025-02-19
GUDID 08719992508204 Enraf-Nonius B.V.	EN-Dynamic Abdominal Trainer	2025-02-19
GUDID 08719992508198 Enraf-Nonius B.V.	EN-Dynamic Pull Down	2025-02-19
GUDID 08719992508181 Enraf-Nonius B.V.	EN-Dynamic Back Trainer	2025-02-19
GUDID 08719992508174 Enraf-Nonius B.V.	EN-Dynamic Chest Press	2025-02-19
GUDID 08719992508693 Enraf-Nonius B.V.	Zimmer XB and 6 digits	2023-10-16
GUDID 08719992508662 Enraf-Nonius B.V.	Dynatronics Ultra	2023-06-16
GUDID 08719992508525 Enraf-Nonius B.V.	Manumed	2023-06-16
GUDID 08719992508082 Enraf-Nonius B.V.	Manumed ST	2023-06-16
GUDID 08719992508075 Enraf-Nonius B.V.	ManuMax	2023-06-16
GUDID 08719992508068 Enraf-Nonius B.V.	ManuXelect	2023-06-16
PMN K153559 | IPF ENRAF-NONIUS B.V. [NEW COMPANY INVESTMENTS B.V.]	Omniversa	2016-12-07
PMN K153559 | IMG ENRAF-NONIUS B.V. [NEW COMPANY INVESTMENTS B.V.]	Omniversa	2016-12-07
PMN K153559 | GZJ ENRAF-NONIUS B.V. [NEW COMPANY INVESTMENTS B.V.]	Omniversa	2016-12-07
PMN K151640 | ITH ENRAF-NONIUS B.V. [NEW COMPANY INVESTMENTS B.V.]	Eltrac 471	2015-12-17
PMN K151640 | ITH ENRAF-NONIUS B.V. [NEW COMPANY INVESTMENTS B.V.]	Dynatron SmarTRAC	2015-12-17
PMN K151640 ENRAF-NONIUS B.V.	ELTRAC 471	2015-10-16

Related Finance Registrations

NCAGE Code	H2603	ENRAF-NONIUS B.V.
CAGE Code	H2603	ENRAF-NONIUS B.V.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200725155	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	28 PKG
2020042016206	Anvers,Belgium -> Los Angeles, California	ELECTRICAL MEDICAL EQUIPMENT	5 PCS
2020040237785	Anvers,Belgium -> Savannah, Georgia	ELECTRICAL MEDICAL EQUIPMENT	5 PCS
2020022462644	Rotterdam,Netherlands -> Oakland, California	ELECTRICAL MEDICAL EQUIPMENT	7 PCS
2019120520578	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	28 PKG
2019111947873	Anvers,Belgium -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	28 PKG
2019090727582	Rotterdam,Netherlands -> Savannah, Georgia	TABLES	12 PKG
2019071846623	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	1 PKG