Domico Med Device

FDA Filings

This page includes the latest FDA filings for Domico Med Device. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Domico Med Device holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

KOHLBRAT & BUNZ

FDA Registration(s)

Registration Number	3005588647
FEI Number	3005588647
Name	KOHLBRAT & BUNZ
Owner & Operator	Domico Med-Device
Contact Address	14241 N. Fenton RD Fenton MI 48430 US
Official Correspondent	Domico Med-Device 1-810-7505300-5359
US Agent	Nicholas Sievers Domico Med-Device 810 7505300 5359 nsievers@domicomed.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	Loretostrasse 4-8 Radstadt Salzburg, 5550 AT
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device

Registration Number	3014680784
FEI Number	3014680784
Name	DOMICO MED-DEVICE
Owner & Operator	Domico Med-Device
Contact Address	14241 N. Fenton RD Fenton MI 48430 US
Official Correspondent	Domico Med-Device 1-810-7505300-5359
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	14241 N. Fenton RD Fenton, MI 48430 US
Establishment Type	Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
FZF KOHLBRAT & BUNZ [Domico Med-Device]	Arm splints; Child splints; Dual leg splints; Hand, Foot, Wrist, Ankle, Leg Splints; Head splints; Infant Splints	2018-05-29
FZF DOMICO MED-DEVICE	Arm splints; Child splints; Dual leg splints; Hand, Foot, Wrist, Ankle, Leg Splints; Head splints; Infant Splints	2018-05-29