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AMH Control 660-20

by Fujirebio Diagnostics, Inc.

Ref 660-20

AMH Control 660-20 is a device classified as Class C in the EU and Class I in the US made by Fujirebio Diagnostics, Inc., registered in EUDAMED on 30 Jul 2026 (Basic UDI-DI 7350066140579M) and listed in FDA GUDID since 25 Apr 2019 (UDI-DI 17350066140579), active as of 23 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 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/IVDR EUDAMED Number7350066140579M Basic UDI-DI 17350066140579UDI-DIDate30 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17350066140579 UDI-DI Date25 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 7350066140579M registered 30 Jul 2026 Active
  • FDA GUDID UDI-DI 17350066140579 listed 25 Apr 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 17350066140579
  2. Registered EUDAMED 7350066140579M

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  • Withdrawn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
AMH Control
Generic name
Anti-Mullerian hormone (AMH) IVD, control
Model / reference
660-20
Primary DI / UDI-DI
17350066140579
Basic UDI-DI
7350066140579M
FDA product code
JJY
EMDN code
W0102152099 Controls- immunochemistry - other
GMDN term
Anti-Mullerian hormone (AMH) IVD, control
Device class
Class C EUDAMED
Class I GUDID
Regulation number
862.1660
EU registration type
Standard device
EU market of registration
Sweden
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class C
GUDID
Class I

Device class is stated on each registry's own scale: Class C 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: Anti-Mullerian hormone (AMH) IVD, control

Similar devices in this category

Other devices filed under CONTROLS- IMMUNOCHEMISTRY - OTHER.

Other devices from Fujirebio Diagnostics, Inc.

See all devices from Fujirebio Diagnostics, Inc. →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)