Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030941

FEI Number

3005979524

Entity Name

NOLATO MEDITOR AB

City/State/Country

TOREKOV Skane, SE

Establishment Address

Nolatovagen, TOREKOV Skane 269 78, SE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NOLATO MEDITOR AB (Owner Number: 8030941)

Owner / Operator Contact Address

Nolatovagen, --, Torekov, SE-M 269 78, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PhaSeal Optima Infusion Clamp, M25-O Draegerwerk AG & Co. KGaA Draegerwerk AG & Co. KGaA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2019-11-22
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-06-14
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2024-06-14

Official Correspondent

Karin Dedering

US Agent Details

Russell Steele Business: Nolato Contour Email: russell.steele@Nolato.com Phone: (715) 6887344

Related Public Records

Same Entity

NOLATO MEDITOR AB

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
3030433705	TMR PLASTICS	Bydgoszcz Pomorskie, PL
8030607	Industrias Apson S.A de C.V	AGUA PRIETA Sonora, MX
3011642792	Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, MX
3005023997	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	SHANGHAI, CN
3003152976	BECTON DICKINSON, S.A.	SAN AGUSTIN DE GUADALIX Madrid (Province), ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030941. Last updated year: 2026. Please use registration number 8030941 when referencing this establishment in official correspondence.