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Temperature Probe rectal/oral, adult, 3m, reusable

by Edan Instruments, Inc. 7 variants

Ref 01.15.040227, 01.15.040421

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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/MDR EUDAMED Number69444138TPG5 Basic UDI-DI Date29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413804647 UDI-DI Date1 Sep 2016ListedStatusListed 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.

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  • Withdrawn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
Temperature Probe
Generic Name
General-purpose patient temperature probe, reusable
Model / Reference
01.15.040227 EUDAMED
01.15.040421 EUDAMED
rectal/oral GUDID
adult GUDID
3m GUDID
reusable GUDID
Primary DI / UDI-DI
06944413804647, 06944413804722
Basic UDI-DI
69444138TPG5
Direct Marketing DI
06944413804722
06944413804647
FDA Product Code
FLL
EMDN Code
V03010299, Z1203020280
GMDN Term
General-purpose patient temperature probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
880.2910
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01.15.040227
01.15.040421
GUDID
rectal/oral, adult, 3m, reusable
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Serial Number YesGUDIDNoGUDID
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No