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Timestrip® Plus Timestrip® Blood Temp 10 (BT10)

by Timestrip UK Limited

Ref 800-278

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506057937BTXXER Basic UDI-DI 05060579370008UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060579370008 UDI-DI Date23 Sep 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Timestrip® Blood Temp 10 EUDAMED
Timestrip® Plus GUDID
Generic Name
Medical product temperature point indicator, thermochemical
Device Name
Timestrip® Blood Temp 10 (BT10)
Model / Ref / Catalog
800-278, Timestrip® Blood Temp 10 (BT10)
Primary DI / UDI-DI
05060579370008
Basic UDI-DI
506057937BTXXER
FDA Product Code
KSS
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Medical product temperature point indicator, thermochemical
Device Class
Class I
Regulation Number
864.9050
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
800-278
GUDID
Timestrip® Blood Temp 10 (BT10)

Other devices from Timestrip UK Limited

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No