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Flexiwrap Adhesive Strips

by Nonin Medical, Inc. 2 variants

Ref 4097-000Model MODEL 8000JFW, ADULT 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-00833166000627 Basic UDI-DI 00833166000627UDI-DIDate11 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00833166000627 UDI-DI Date3 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.

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  • Withdrawn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
Nonin GUDID
Generic Name
Dressing-fixation skin adhesive tape, non-silicone
Model / Reference
MODEL 8000JFW EUDAMED
ADULT FLEXIWRAP SENSOR DISP EUDAMED
4097-000 EUDAMED
8000JFW GUDID
Primary DI / UDI-DI
00833166000627
Basic UDI-DI
B-00833166000627
FDA Product Code
DQA
EMDN Code
C900301 Pulse oximeter sensors
GMDN Term
Dressing-fixation skin adhesive tape, non-silicone
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
MODEL 8000JFW, ADULT FLEXIWRAP SENSOR DISP
4097-000
GUDID
8000JFW
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

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

Related devices

Category: Pulse oximeter probe, single-use

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

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

Other properties (18)

  • 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
  • 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