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TBD-2™ Decalcifier

by Richard-Allan Scientific LLC 2 variants

Part of a family of 7 devices: see the family page

Ref 6764004

TBD-2™ Decalcifier (6764004) is a device classified as Class A in the EU and Class I in the US made by Richard-Allan Scientific LLC, registered in EUDAMED on 4 Dec 2025 (Basic UDI-DI 0673693RAS009RP) and listed in FDA GUDID since 26 Jul 2024 (UDI-DI 00673693228282), active as of 22 Oct 2026.

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

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0673693RAS009RP Basic UDI-DI 00673693228282UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00673693228282 UDI-DI Date26 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0673693RAS009RP registered 4 Dec 2025 Active
  • FDA GUDID UDI-DI 00673693228282 listed 26 Jul 2024 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00673693228282
  2. Registered EUDAMED 0673693RAS009RP

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
TBD-2™ Decalcifier EUDAMED
Epredia GUDID
Generic name
Decalcifying solution IVD
Model / Ref / Catalog
6764004, TBD-2 Decalcifier
Primary DI / UDI-DI
00673693228282
Basic UDI-DI
0673693RAS009RP
Direct marketing DI
00673693228282
FDA product code
KDX
EMDN code
W01030708 Stain solutions (histology/cytology)
GMDN term
Decalcifying solution IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6764004
GUDID
TBD-2 Decalcifier
Device classEUDAMED
Class A
GUDID
Class I

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

Manufacturer details

EUDAMED SRN
US-MF-000008261
Authorised representative
Epredia Netherlands B.V. NL-AR-000001488

Similar devices in this category

Other devices filed under STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY).

Other devices from Richard-Allan Scientific LLC

See all devices from Richard-Allan Scientific LLC →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)