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Alivia

by TensCare Ltd

Ref K-ALIVIA

K-ALIVIA is a medical device (EU MDR Class IIa; EMDN category pelvic floor rehabilitation devices) made by TensCare Ltd, registered in EUDAMED on 2 Sep 2024 (Basic UDI-DI 5033435K00138DSU), active as of 22 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number5033435K00138DSU Basic UDI-DI Date2 Sep 2024RegisteredStatusActive

Official records

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
K-ALIVIA
Primary DI / UDI-DI
05033435136278, 05033435135967
Basic UDI-DI
5033435K00138DSU, 5033435K00138ZU
EMDN code
U070399 Pelvic floor rehabilitation devices - other
Device class
Class IIa
System or procedure pack
Procedure pack
EU registration type
Standard device
System or procedure pack
EU market of registration
Netherlands
Medical purpose
Alivia is a medical device designed to be used in the home healthcare environment to treat symptoms of urinary and/or faecal incontinence and is suitable for use by all who can control the device and understand the instructions. Alivia may also help to relieve the pain of secondary menstrual pain due to conditions such as endometriosis, fibroids or pelvic inflammatory disease.

Manufacturer details

EUDAMED SRN
GB-MF-000004156
Authorised representative
Advena Limited MT-AR-000000234

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES - OTHER.

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Properties

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