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RespArray Temperature probe 02.57.225243

by Edan Instruments, Inc.

Ref RPAYICVTMA

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 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/MDR EUDAMED Number69444138TP34E Basic UDI-DI 06944413839526UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413839526 UDI-DI Date19 Apr 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Temperature Probe EUDAMED
RespArray Temperature probe GUDID
Generic Name
General-purpose patient temperature probe, reusable
Model / Reference
RPAYICVTMA EUDAMED
02.57.225243 GUDID
Primary DI / UDI-DI
06944413839526
Basic UDI-DI
69444138TP34E
Direct Marketing DI
06944413839526
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
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RPAYICVTMA
GUDID
02.57.225243
Device ClassEUDAMED
Class IIb
GUDID
Class II

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Properties

  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • 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
  • Serial Number: No