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Set Natural colors Toric

by Solotica Industria e Comercio Ltda

Ref 0413Model Solotica Contact Lens

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number78990316TNL5 UDI-DI Date25 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number78990316LENTES35 Basic UDI-DI 78990316TNL5UDI-DIDate12 Mar 2026RegisteredStatusActive

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Set Natural colors Toric EUDAMED
Kit Natural Colors Toric GUDID
Generic Name
Soft corrective contact lens, daily-wear
Device Name
Solotica Contact Lens
Model / Reference
Solotica Contact Lens, 0413
Primary DI / UDI-DI
78990316TNL5 EUDAMED
07908532323167 GUDID
Basic UDI-DI
78990316LENTES35
510(k) Number
FDA Product Code
LPL
EMDN Code
Q0210040102 Contact lenses - hydrogel, reusable
GMDN Term
Soft corrective contact lens, daily-wear
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
886.5925
Special Device Type
Standard soft contact lenses
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
78990316TNL5
GUDID
07908532323167
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
BR-MF-000015792
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Solotica Industria E Comercio Ltda

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No