Statistics for Wellspect HealthCare

171Total Devices

4Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

4Countries

Certificate health for Wellspect HealthCare

No certificates registered for this manufacturer.

Devices by risk class

Device catalog for Wellspect HealthCare

Showing 76–100 of 171 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
LoFric Primo	`41012`	`07333387043005`	1	On the market
LoFric Primo	`41510`	`07333387043173`	1	On the market
LoFric Primo	`41016`	`07333387043029`	1	On the market
LoFric Primo	`41414`	`07333387043166`	1	On the market
LoFric Primo	`41110`	`07333387043067`	1	On the market
LoFric Primo	`41310`	`07333387043081`	1	On the market
LoFric Primo	`41408`	`07333387043135`	1	On the market
LoFric Primo	`41010`	`07333387042992`	1	On the market
LoFric Primo	`41008`	`07333387042985`	1	On the market
LoFric Primo	`41518`	`07333387043210`	1	On the market
LoFric Primo	`41014`	`07333387043012`	1	On the market
LoFric Primo	`41106`	`07333387043043`	1	On the market
LoFric Sense Nelaton 15cm CH08	`4160865`	`07333387021300`	1	On the market
LoFric Sense Nelaton 15cm CH08	`4160870`	`07333387021331`	1	On the market
LoFric Sense Nelaton 15cm CH08	`4160820`	`07333387021034`	1	On the market
Navina Catheter Set Regular	`6894000`	`07333387024776`	1	On the market
Navina Catheter Set Regular	`6894096`	`07333387050706`	1	On the market
Navina Catheter Set Regular	`6894070`	`07333387024899`	1	On the market
Navina Catheter Set Regular	`6894030`	`07333387024837`	1	On the market
Navina Catheter Set Regular	`07333387024929`	`07333387024929`	1	On the market
Navina Catheter Set Regular	`6894081`	`07333387024950`	1	On the market
Navina Catheter Set Regular	`6894010`	`07333387024806`	1	On the market
Navina Mini Extension Set	`6930800`	`07333387047454`	1	On the market
Navina Mini Set	`6930700`	`07333387047416`	1	On the market
Navina Mini Start Set	`6931030`	`07333387047553`	1	On the market

2 3 4 5 6

Market presence of Wellspect HealthCare

Devices placed in 4 countries

Sweden110
Denmark30
Türkiye30
Italy1

EUDAMED update: Feb 20, 2025

Wellspect HealthCare

SE-MF-000026271

Active

Address: Aminogatan, 1 431 21 Mölndal
Role: Manufacturer
Date of registration: Jul 20, 2022
Country: SE Sweden

About Wellspect HealthCare

SRN: SE-MF-000026271
Role: Manufacturer
Country: Sweden
Organization name: Wellspect HealthCare
EU VAT number: SE559332067301
EORI: SE5593320673
Trade register: 559332-0673
Date of registration: Jul 20, 2022

Contact details for Wellspect HealthCare

Address: 1, AMINOGATAN 431 21 MÖLNDAL SWEDEN
Phone: +46 3 137 64 000
Email: Wellspect-QARA@wellspect.com
Website: www.wellspect.com

Validator

Name: Swedish Medical Products Agency
SRN: SE-CA-030
Phone: +46 18 17 46 00
Email: registrator@lakemedelsverket.se

Officers and regulatory representatives of Wellspect HealthCare

ERICSON Christina
The Technical Documentation and the EU Declaration of Conformity as stated in Article 15 3(b) of MDR.
Hidden
RAMZI Emad
The Post-Market Surveillance obligations and the Vigilance Reporting obligations as stated in Article 15 3(c) and 3(d) of MDR.
Hidden
HINDRICHSEN Pia
The Final Release of Products as stated in Article 15 3(a) of MDR.
Hidden
BAS Seda
The Final Release of Products as stated in Article 15 3(a) of MDR.
Hidden