Sulzer Mixpac Deutschland G M B H

FDA Filings

This page includes the latest FDA filings for Sulzer Mixpac Deutschland G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3007113445

FEI Number

3007113445

Name

Sulzer Mixpac Deutschland GmbH

Owner & Operator

Sulzer Mixpac Deutschland GmbH

Contact Address

Zum Kesselort 53
Kiel DE-SH Schleswig-Holstein 24149 DE

Official Correspondent

Kai Brendel
049-431-979979-77

US Agent

Leif Klein
Sulzer Mixpac USA, Inc.
203 2452556
leif.klein@gmail.com

Importing Logistics Registration

Importer	Sulzer Mixpac USA, Inc.
Address	63 Wall Street Madison, CT 06443 UNITED STATES
Importer Type	Agent

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Zum Kesselort 53
Kiel Schleswig-Holstein, 24149 DE

Establishment Type

Manufacture Medical Device
Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
EIF Sulzer Mixpac Deutschland GmbH	Handpiece for suction needles	2019-05-22
PMN K111876 \| KLE Sulzer Mixpac Deutschland GmbH	Prelude One UD	2017-08-14
PMN K894890 \| EBF Sulzer Mixpac Deutschland GmbH	CRYSTALLINE C2 AND CRYSTALLINE L3	2017-08-09
KXR Sulzer Mixpac Deutschland GmbH	Appliquator	2016-12-08
DZN Sulzer Mixpac Deutschland GmbH	Suction Needles	2016-12-08
DZN Sulzer Mixpac Deutschland GmbH	Flexible Steel Endo Irrigation Needles	2016-12-08
DZN Sulzer Mixpac Deutschland GmbH	Endo Irrigation Needles	2016-12-08
DZN Sulzer Mixpac Deutschland GmbH	Endo Evacuation Needles	2016-12-08
DZM Sulzer Mixpac Deutschland GmbH	Painless Steel	2016-12-08

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929133	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110, 39233010	204 PKG
202009243255	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	87 PKG
202009176455	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	87 PKG
2020090224846	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	87 PKG
2020082735927	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	87 PKG
20200822457	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110, 39233010	320 PKG
2020082027596	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	195 PKG
2020080851944	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	SYRINGES, INCLUDING NEEDLES, FOR MEDICAL PURP OSESHS CODE: 90183900, 90183110	195 PKG