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Retrax Solution 15 mL 15600

by Pascal Company, Inc.

Ref 15600

Retrax Solution 15 mL 15600 is a gingival retraction solution (EU MDR Class I; FDA unclassified; FDA product code MVL, Cord, Retraction) made by Pascal Company, Inc., registered in EUDAMED on 9 Apr 2024 (Basic UDI-DI 03108665002GM) and listed in FDA GUDID since 29 Jan 2019 (UDI-DI 00310866000817), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03108665002GM Basic UDI-DI 00310866000817UDI-DIDate9 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00310866000817 UDI-DI Date29 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 03108665002GM registered 9 Apr 2024 Active
  • FDA GUDID UDI-DI 00310866000817 listed 29 Jan 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00310866000817
  2. Registered EUDAMED 03108665002GM

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  • Withdrawn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
Retrax AS Solution EUDAMED
Retrax Solution 15 mL GUDID
Generic name
Gingival retraction solution
Model / Ref / Catalog
15600
Primary DI / UDI-DI
00310866000817
Basic UDI-DI
03108665002GM
FDA product code
MVL
EMDN code
Q010204 Retraction wires and gingival retractors
GMDN term
Gingival retraction solution
Device class
Class I EUDAMED
U GUDID
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
U

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), U in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Gingival retraction solution

Similar devices in this category

Other devices filed under RETRACTION WIRES AND GINGIVAL RETRACTORS.

Other devices from Pascal Company, Inc.

See all devices from Pascal Company, Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)