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FineEtch-37 1.2ml

by Spident

Ref #3601P04

FineEtch-37 1.2ml (#3601P04) is a device classified as Class IIa in the EU and Class II in the US made by Spident, registered in EUDAMED on 8 May 2026 (Basic UDI-DI B-08809262954012) and listed in FDA GUDID since 20 Apr 2026 (UDI-DI 08809262954012), active as of 23 Oct 2026.

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

CE MDD

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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809262954012 Basic UDI-DI 08809262954012UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809262954012 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08809262954012 registered 8 May 2026 Active
  • FDA GUDID UDI-DI 08809262954012 listed 20 Apr 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809262954012
  2. Registered EUDAMED B-08809262954012

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
FineEtch-37 1.2ml EUDAMED
FineEtch GUDID
Generic name
Dental etching solution syringe
Model / Ref / Catalog
#3601P04, SPIDENT FINE ETCH 37 - 1.2 4ea
Primary DI / UDI-DI
08809262954012
Basic UDI-DI
B-08809262954012
FDA product code
KLE
EMDN code
Q01010402 Enamel-dentinal etching materials
GMDN term
Dental etching solution syringe
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3200
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
#3601P04
GUDID
SPIDENT FINE ETCH 37 - 1.2 4ea
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
KR-MF-000008691
Authorised representative
AR Experts B.V. NL-AR-000023989

Similar devices in this category

Other devices filed under ENAMEL-DENTINAL ETCHING MATERIALS.

Other devices from Spident

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Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)