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Diaceram 2-step 101RA-0

by Diaswiss SA

Ref 101RA-0Model Diaceram 2-step

Diaceram 2-step 101RA-0 is a device classified as Class IIa in the EU and Class I in the US made by Diaswiss SA, registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI B-07630049984134) and listed in FDA GUDID since 2 Oct 2023 (UDI-DI 07630049984134), 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-07630049984134 Basic UDI-DI 07630049984134UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07630049984134 UDI-DI Date2 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-07630049984134 registered 23 Jul 2026 Active
  • FDA GUDID UDI-DI 07630049984134 listed 2 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07630049984134
  2. Registered EUDAMED B-07630049984134

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  • Withdrawn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
Diaceram 2-step
Generic name
Dental abrasive point, reusable
Model / reference
101RA-0, Diaceram 2-step
Primary DI / UDI-DI
07630049984134
Basic UDI-DI
B-07630049984134
FDA product code
EHL
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dental abrasive point, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6010
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Dental abrasive point, reusable

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Diaswiss SA

See all devices from Diaswiss SA →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)