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CuboAi Smart Temp

by iWEECARE Co., Ltd.

Ref STP-MB01-1

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04712977931053 Basic UDI-DI 04712977931053UDI-DIDate10 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04712977931053 UDI-DI Date18 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
CuboAi Smart Temp EUDAMED
Temp Pal (Smart Thermometer Patch), Smart Temp GUDID
Generic Name
Wireless patient thermometer, reusable
Device Name
Temp Pal (Smart Thermometer Patch)
Model / Reference
STP-MB01-1
Primary DI / UDI-DI
04712977931053 EUDAMED
04712977931060 GUDID
Basic UDI-DI
B-04712977931053
510(k) Number
FDA Product Code
FLL
EMDN Code
V0301010201 Contact digital thermometers (including probes)
GMDN Term
Wireless patient thermometer, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.2910
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04712977931053
GUDID
04712977931060
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
TW-MF-000045851
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from iWEECARE Co., Ltd.

Properties

  • Reusable
  • Measuring Function
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No