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Flexiwrap Adhesive Strips

by Nonin Medical, Inc. 2 variants

Ref 9947-001, 4775-000Model 70276, MODEL 8000JFW ADULT FLEXW DISP, 954I, INFANT FLEXIWRAP SENSOR DISP

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

CE MDD

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/MDD EUDAMED NumberB-00849686085976 Basic UDI-DI Date12 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00849686085976 UDI-DI Date17 Sep 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.

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  • Withdrawn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
Flexiwrap Adhesive Strips EUDAMED
Reusable Pulse Oximetry Soft Sensors GUDID
Generic Name
Pulse oximeter probe, reusable
Model / Reference
70276, MODEL 8000JFW ADULT FLEXW DISP, 9947-001, 954I, INFANT FLEXIWRAP SENSOR DISP, 4775-000
Primary DI / UDI-DI
00849686085976, 00833166008913
Basic UDI-DI
B-00849686085976, B-00833166008913
FDA Product Code
DQA
EMDN Code
Z1203020408, C900301
GMDN Term
Pulse oximeter probe, reusable
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000008228
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

  • Single Use
  • Administering Medicine
  • Measuring Function
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No