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Disposable SpO2 Sensors SSD-001-W09AN

by Orantech Inc.

Ref SSD-001-W09AN

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

CE MDD

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/MDD EUDAMED NumberB-06941691927785 Basic UDI-DI 06941691927785UDI-DIDate4 Dec 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06941691927785 UDI-DI Date24 Dec 2020ListedStatusListed 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Spo2 sensor EUDAMED
Disposable SpO2 Sensors GUDID
Generic Name
Pulse oximeter probe, single-use
Model / Ref / Catalog
SSD-001-W09AN, II
Primary DI / UDI-DI
06941691927785
Basic UDI-DI
B-06941691927785
510(k) Number
FDA Product Code
DQA
EMDN Code
C900301 Pulse oximeter sensors
GMDN Term
Pulse oximeter probe, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K181270)

Other devices from Orantech Inc.

See all devices from Orantech Inc. →

Properties

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

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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