Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615827

FEI Number

3003080079

Entity Name

WILAMED GMBH

City/State/Country

Kammerstein Bavaria, DE

Establishment Address

Aurachhoehe 5 7, Kammerstein Bavaria 91126, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WILAmed GmbH (Owner Number: 10033146)

Owner / Operator Contact Address

Aurachhoehe 5 7, Kammerstein, DE-BY 91126, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disp, 15mm, Ped, Non-Htd, Passive, Single Disposable Active Exhalation Valve Disposable Active Exhalation Valve (10 pack) Disposable Swivel Passive Exhalation Port (10 pack) Disp, 22mm, Adult, Non-Htd, Passive, single Disp, 15mm, Ped, Non-Htd, Active, Single Disp, 22mm, Adult, Non-Htd, Active, Single Disp, 22mm, Adult, Non-Htd, Passive, 10 pack Disp, 15mm, Ped, Non-Htd, Passive, 10 pack Disp, 15mm, Ped, Non-Htd, Active, 10 pack Disposable Swivel Passive Exhalation Port Disp, 22mm, Adult, Non-Htd, Active, 10 pack Clearline Airlife DuoTherm Humidification System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2017-11-13
NOU	Continuous, Ventilator, Home Use	Anesthesiology	Class 2	868.5895	2019-08-13
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2019-08-13
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2017-11-13
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2026-05-28
QOP	Respiratory Humidifier For Emergency Use	Unknown	Class N	N/A	2021-09-03
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2011-08-29

Official Correspondent

No official correspondent registered.

US Agent Details

Kevin Walls Business: Regulatory Insight, Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

WILAmed GmbH

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
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615827. Last updated year: 2026. Please use registration number 9615827 when referencing this establishment in official correspondence.