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Atellica CH RF 11097618

by Siemens Healthcare Diagnostics Inc.

Ref 11097618Model IVDR_67_TTN_DUB-C_B_REAG_RF

Atellica CH RF 11097618 is a device classified as Class B in the EU and Class II in the US made by Siemens Healthcare Diagnostics Inc., registered in EUDAMED on 23 Jul 2026 (Basic UDI-DI 0405686901767WD), cleared under FDA 510(k) K972220 on 9 Sep 1997 and listed in FDA GUDID since 22 Dec 2017 (UDI-DI 00630414595603), active as of 24 Oct 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972220

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number0405686901767WD Basic UDI-DI 00630414595603UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00630414595603 UDI-DI Date22 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972220 Date9 Sep 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0405686901767WD registered 23 Jul 2026 Active
  • FDA 510(k) K972220 decided 9 Sep 1997 Active
  • FDA GUDID UDI-DI 00630414595603 listed 22 Dec 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-0282-2020 FDA Class II initiated 9 Aug 2019

    The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

Timeline

4 dated events

  1. Cleared FDA 510(k) K972220
  2. Listed FDA GUDID 00630414595603
  3. Recall initiated FDA recalls Z-0282-2020
  4. Registered EUDAMED 0405686901767WD

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Atellica CH Rheumatoid Factor (RF) EUDAMED
Atellica CH RF GUDID
Generic name
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Device name
IVDR_67_TTN_DUB-C_b_reag_rf
Model / Ref / Catalog
11097618, IVDR_67_TTN_DUB-C_B_REAG_RF
Primary DI / UDI-DI
00630414595603
Basic UDI-DI
0405686901767WD
510(k) Number
FDA product code
DHR
EMDN code
W01021110 Rheumatoid factors
GMDN term
Rheumatoid factor IVD, kit, nephelometry/turbidimetry
Device class
Class B EUDAMED
Class II GUDID
Regulation number
866.5775
EU registration type
Standard device
EU market of registration
Germany
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: Rheumatoid factor IVD, kit, nephelometry/turbidimetry

Cleared under the same submission (K972220)

Similar devices in this category

Other devices filed under RHEUMATOID FACTORS.

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Contains human tissues or cells
  • Contains animal tissues or cells
  • Reagent
  • Professional testing
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)