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Wellspect HealthCare

Sweden·SE-MF-000026271

Last updated September 17, 2026

About

We support people suffering from urinary and bowel dysfunction by providing innovative solutions that enable people to live more independent and dignified lives

From the manufacturer's own website. Source

Information

Country: Sweden
Address: 1, Aminogatan, Mölndal, Sweden
Website: www.wellspect.com
LinkedIn: linkedin.com/company/wellspect-healthcare
Facebook: facebook.com/wellspect
Email: [email protected]
Phone: +46 3 137 64 000
PRRC Contact: Christina Ericson
EUDAMED SRN: SE-MF-000026271
FDA FEI Number: 3009632672
DUNS Number: —

Catalogue (80)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Navina Smart System Cone	6901980	EUDAMED	Class IIa	Active
Navina Smart Control Unit	6901445	EUDAMED	Class IIa	Active
hi-slip plus	TRHSPM4020B	EUDAMED	Class I	Active
hi-slip plus	TRHSPP3008B	EUDAMED	Class I	Active
hi-slip plus	TRHSPT4010B	EUDAMED	Class I	Active
hi-slip plus	TRHSPF2012B	EUDAMED	Class I	Active
hi-slip plus	TRHSPF2014B	EUDAMED	Class I	Active
hi-slip plus	TRHSPM4018B	EUDAMED	Class I	Active
hi-slip plus	TRHSPF2010B	EUDAMED	Class I	Active
Navina™ Classic Control Unit	6901311	EUDAMED	Class I	Active
LoFric Primo	41514	EUDAMEDFDA UDI	Class I	Active
LoFric Primo	41314	EUDAMEDFDA UDI	Class I	Active
Navina Mini Set	6930700	EUDAMED	Class I	Active
hi-slip plus	TRHSPF1512B	EUDAMED	Class I	Active
hi-slip plus	TRHSPT4018A	EUDAMED	Class I	Active
Navina™ Classic System Small Refill	6900896	EUDAMED	Class I	Active
hi-slip plus	TRHSPM4012A	EUDAMED	Class I	Active
hi-slip plus	TRHSPF1508A	EUDAMED	Class I	Active
hi-slip plus	TRHSPT4014A	EUDAMED	Class I	Active
Navina Catheter Set Regular	6894081	EUDAMED	Class IIa	Active
hi-slip plus	TRHSPF2016A	EUDAMED	Class I	Active
Navina™ Classic Control Unit	6901312	EUDAMED	Class I	Active
Navina™ Classic System Small	6900796	EUDAMED	Class I	Active
Navina™ Classic System Small	6900770	EUDAMED	Class I	Active
Navina™ Classic System Small	6900745	EUDAMED	Class I	Active
hi-slip plus	TRHSPM4010A	EUDAMED	Class I	Active
LoFric Primo	41318	EUDAMEDFDA UDI	Class I	Active
Navina Catheter Set Regular	07333387024929	EUDAMED	Class IIa	Active
hi-slip plus	TRHSPT4012A	EUDAMED	Class I	Active
LoFric Primo	41414	EUDAMEDFDA UDI	Class I	Active
Navina Catheter Set Regular	6894010	EUDAMED	Class IIa	Active
LoFric Primo	41110	EUDAMEDFDA UDI	Class I	Active
hi-slip plus	TRHSPF1510B	EUDAMED	Class I	Active
Navina™ Classic Control Unit	6901396	EUDAMED	Class I	Active
Navina™ Classic System Regular Refill	6900611	EUDAMED	Class I	Active
LoFric Insti-Cath	40712	EUDAMED	Class I	Active
Navina™ Classic System Regular Refill	6900696	EUDAMED	Class I	Active
Navina Mini Start Set	6931030	EUDAMED	Class I	Active
Navina™ Classic System Regular Refill	6900681	EUDAMED	Class I	Active
Navina™ Classic System Small	6900780	EUDAMED	Class I	Active
Navina™ Classic System Small	6900712	EUDAMED	Class I	Active
Navina™ Classic System Regular	6900596	EUDAMED	Class I	Active
LoFric Primo	41316	EUDAMEDFDA UDI	Class I	Active
Navina™ Classic System Small Refill	6900845	EUDAMED	Class I	Active
LoFric Primo	41108	EUDAMEDFDA UDI	Class I	Active
LoFric Primo	41010	EUDAMEDFDA UDI	Class I	Active
LoFric Sense Nelaton 15cm CH08	4160865	EUDAMED	Class I	Active
LoFric Sense Nelaton 15cm CH08	4160820	EUDAMED	Class I	Active
Navina™ Classic System Regular	6900581	EUDAMED	Class I	Active
Navina™ Classic System Small Refill	6900865	EUDAMED	Class I	Active

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