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SZcaremed

by Shenzhen Caremed Medical Technology Co., Ltd.

Ref T2252-AS

SZcaremed (T2252-AS) is a device classified as Class IIa in the EU and Class II in the US made by Shenzhen Caremed Medical Technology Co., Ltd., registered in EUDAMED on 15 Nov 2023 (Basic UDI-DI B-06970758502641), cleared under FDA 510(k) K182751 on 6 Sep 2019 and listed in FDA GUDID since 9 Jul 2026 (UDI-DI 06970758502641), active as of 22 Oct 2026.

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

CE MDD 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) K182751

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06970758502641 UDI-DI Date9 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06970758502641 Basic UDI-DI 06970758502641UDI-DIDate15 Nov 2023RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182751 Date6 Sep 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06970758502641 registered 15 Nov 2023 Active
  • FDA 510(k) K182751 decided 6 Sep 2019 Active
  • FDA GUDID UDI-DI 06970758502641 listed 9 Jul 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182751
  2. Registered EUDAMED B-06970758502641
  3. Listed FDA GUDID 06970758502641

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
SZcaremed EUDAMED
Caremed GUDID
Generic name
General-purpose patient temperature probe, reusable
Device name
Temperature Probe
Model / reference
T2252-AS EUDAMED
TRAS-2252 GUDID
Primary DI / UDI-DI
06970758502641
Basic UDI-DI
B-06970758502641
510(k) Number
FDA product code
FLL
EMDN code
V03010199 Thermometers - other
GMDN term
General-purpose patient temperature probe, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.2910
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
T2252-AS
GUDID
TRAS-2252
Device classEUDAMED
Class IIa
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
CN-MF-000010579
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Similar devices in this category

Other devices filed under THERMOMETERS - OTHER.

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Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)