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Salvafix

by Medi Care System S.L.U. 27 variants

Ref SVF3002P

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number843603535SVFNC Basic UDI-DI 08436035355600UDI-DIDate2 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436035355600 UDI-DI Date22 Nov 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Salvafix EUDAMED
Salvafix Memory PRO GUDID
Generic Name
Limb/torso/head restraint, reusable
Device Name
Sistema de movilidad controlada que permite ampliar o restringir de forma segura, el grado de contención según requiera el tratamiento
Model / Reference
SVF3002P
Description
Restraint Belt with sewed perineal size L
Primary DI / UDI-DI
08436035355600
Basic UDI-DI
843603535SVFNC
Direct Marketing DI
08436035355600
FDA Product Code
FMQ
EMDN Code
M030599 Immobilisation systems and devices - other
GMDN Term
Limb/torso/head restraint, reusable
Device Class
Class I
Regulation Number
880.6760
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
ES-MF-000008420

Other devices from Medi Care System S.L.U.

See all devices from Medi Care System S.L.U. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No