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Temperature Probe rectal/oral, neonatal/Infant, 3m, reusable

by Edan Instruments, Inc. 4 variants

Ref 01.15.040256

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

3 ongoing

Recall on shared 510(k) K232962, K152552, K192514; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138TPG5 Basic UDI-DI 06944413804784UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413804784 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.

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1149-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K232962
    • Ongoing Z-1147-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K152552
    • Ongoing Z-1148-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K192514

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
01.15.040256 EUDAMED
rectal/oral GUDID
neonatal/Infant GUDID
3m GUDID
reusable GUDID
Primary DI / UDI-DI
06944413804784
Basic UDI-DI
69444138TPG5
Direct Marketing DI
06944413804784
510(k) Number
FDA Product Code
FLL
EMDN Code
V03010299 Body temperature monitoring probes - other
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
01.15.040256
GUDID
rectal/oral,neonatal/Infant,3m,reusable
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K152552)

Cleared under the same submission (K192514)

Cleared under the same submission (K232962)

Show all (12)

Cleared under the same submission (K250179)

Show all (12)

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

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

Other properties (20)

  • 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
  • Serial Number: No
  • Expiration Date: No