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ACE Calibrator 06U8201

by Sentinel Ch. Srl

Ref 06U8201

ACE Calibrator 06U8201 is a device classified as Class B in the EU and Class II in the US made by Sentinel Ch. Srl, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 805805668CIACEN01ZZ228N7H) and listed in FDA GUDID since 27 Jan 2025 (UDI-DI 08058056685285), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number805805668CIACEN01ZZ228N7H Basic UDI-DI 08058056685285UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08058056685285 UDI-DI Date27 Jan 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805805668CIACEN01ZZ228N7H registered 4 Nov 2026 Active
  • FDA GUDID UDI-DI 08058056685285 listed 27 Jan 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08058056685285
  2. Registered EUDAMED 805805668CIACEN01ZZ228N7H

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  • Withdrawn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
ACE Calibrator
Generic name
Angiotensin converting enzyme (ACE) IVD, calibrator
Device name
Ace 1
Model / Ref / Catalog
06U8201
Primary DI / UDI-DI
08058056685285
Basic UDI-DI
805805668CIACEN01ZZ228N7H
FDA product code
JIT
EMDN code
W0101050302 Calibrators single component (cc)
GMDN term
Angiotensin converting enzyme (ACE) IVD, calibrator
Device class
Class B EUDAMED
Class II GUDID
Regulation number
862.1150
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 B
GUDID
Class II

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

Related devices

Category: Angiotensin converting enzyme (ACE) IVD, calibrator

Similar devices in this category

Other devices filed under CALIBRATORS SINGLE COMPONENT (CC).

Other devices from Sentinel Ch. Srl

See all devices from Sentinel Ch. Srl →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (16, all answered No)