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NA SpO Sensor（Single-patient use）- Neonatal

by Edan Instruments, Inc.

Ref 01.57.471749

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K131971; 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69444138SSG8 Basic UDI-DI 06944413805446UDI-DIDate29 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944413805446 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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1145-2026 FDA Class II initiated 24 Oct 2025 on shared 510(k) K131971

    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.

    • Terminated Z-2388-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K131971

    Incorrect CO2 readings with some patient monitors.

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  • Withdrawn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
SpO2 sensor
Generic Name
Pulse oximeter probe, reusable
Model / Reference
01.57.471749 EUDAMED
SpO Sensor（Single-patient use）- Neonatal GUDID
Primary DI / UDI-DI
06944413805446
Basic UDI-DI
69444138SSG8
510(k) Number
FDA Product Code
DQA
EMDN Code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
01.57.471749
GUDID
SpO Sensor（Single-patient use）- Neonatal
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Pulse oximeter probe, reusable

Cleared under the same submission (K131971)

Show all (12)

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties

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

Other properties (18)

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