Skip to content

CIRCA Temperature Standard CS-104

by CIRCA Scientific, Inc.

Ref CS-104

CIRCA Temperature Standard CS-104 is a medical device (EU MDR Class I; FDA Class II; FDA product code FLL, Thermometer, Electronic, Clinical; EMDN category body temperature measuring devices - accessories) made by CIRCA Scientific, Inc., registered in EUDAMED on 15 Jul 2026 (Basic UDI-DI 0851498007TEMPSTD104MX), cleared under FDA 510(k) K222311 on 25 May 2023 and listed in FDA GUDID since 30 Jun 2023 (UDI-DI 00851498007176), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222311

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0851498007TEMPSTD104MX Basic UDI-DI 00851498007176UDI-DIDate15 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00851498007176 UDI-DI Date30 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222311 Date25 May 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0851498007TEMPSTD104MX registered 15 Jul 2026 Active
  • FDA 510(k) K222311 decided 25 May 2023 Active
  • FDA GUDID UDI-DI 00851498007176 listed 30 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222311
  2. Listed FDA GUDID 00851498007176
  3. Registered EUDAMED 0851498007TEMPSTD104MX

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
CIRCA Temperature Standard
Generic name
Electrical-only medical device connection cable tester
Model / reference
CS-104
Primary DI / UDI-DI
00851498007176
Basic UDI-DI
0851498007TEMPSTD104MX
510(k) Number
FDA product code
FLL
EMDN code
V030180 Body temperature measuring devices - accessories
GMDN term
Electrical-only medical device connection cable tester
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.2910
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrical-only medical device connection cable tester

Cleared under the same submission (K222311)

Similar devices in this category

Other devices filed under BODY TEMPERATURE MEASURING DEVICES - ACCESSORIES.

Other devices from CIRCA Scientific, Inc.

See all devices from CIRCA Scientific, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)