Wilamed G M B H

FDA Filings

This page includes the latest FDA filings for Wilamed 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

9615827

FEI Number

3003080079

Name

Kevin Walls

Owner & Operator

WILAmed GmbH

Contact Address

Aurachhoehe 5 7
Kammerstein DE-BY Bayern 91126 DE

US Agent

Kevin Walls
Regulatory Insight, Inc.
720 9625412
720 9625413
kevin@reginsight.com

Importing Logistics Registration

Importer	Respironics, Inc.
Address	1740 Golden Mile Highway Monroeville, PA 15146 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

33 Golden Eagle Lane
Littleton, CO 80127 US

Establishment Type

Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disposable Swivel Passive Exhalation Port	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disposable Swivel Passive Exhalation Port (10 pack)	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disposable Active Exhalation Valve	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disposable Active Exhalation Valve (10 pack)	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Passive, single	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Passive, 10 pack	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Active, Single	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Active, 10 pack	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Passive, Single	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Passive, 10 pack	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Active, Single	2019-08-13
PMN K181166 \| NOU Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Active, 10 pack	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disposable Swivel Passive Exhalation Port	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disposable Swivel Passive Exhalation Port (10 pack)	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disposable Active Exhalation Valve	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disposable Active Exhalation Valve (10 pack)	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Passive, single	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Passive, 10 pack	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Active, Single	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 22mm, Adult, Non-Htd, Active, 10 pack	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Passive, Single	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Passive, 10 pack	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Active, Single	2019-08-13
PMN K181166 \| CBK Kevin Walls [WILAmed GmbH]	Disp, 15mm, Ped, Non-Htd, Active, 10 pack	2019-08-13

Related Finance Registrations

NCAGE Code	DM029	WILAMED GMBH
CAGE Code	DM029	WILAMED GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200929102361	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	3917330000 1134065 5000 PIEC ES INVOICE(S): 4205259	13 CTN
2020092862143	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1073222 300 PIECE S INVOICE(S): 4205349	25 CTN
2020092862156	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1132340 720 PIECE S INVOICE(S): 4205304	24 CTN
2020092862141	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1132340 580 PIECE S INVOICE(S): 4205350	20 CTN
2020092862101	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1127306 1000 PIEC ES INVOICE(S): 4205101	22 CTN
2020092862101	Bremerhaven,Federal Republic of Germany -> New York, New York	3917390050 1073227 300 PIECE S INVOICE(S): 4205202	22 CTN
2020092862125	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1073225 300 PIECE S INVOICE(S): 4205050 & 4205 136	10 CTN
2020092862113	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1127306 100 PIECE S INVOICE(S): 4205430	22 CTN
2020092862113	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1134065 5000 PIEC ES INVOICE(S): 4205467	22 CTN
2020092671125	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1127306 100 PIECE S INVOICE(S): 4205430	22 CTN
2020092671125	Bremerhaven,Federal Republic of Germany -> New York, New York	3917330000 1134065 5000 PIEC ES INVOICE(S): 4205467	22 CTN