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Redsense FOE

by Redsense Medical AB Sweden EUDAMEDGUDID

Ref RE-1-RE201Model Redsense Alarm fiber optic extension (FOE) Product code ODXEMDN F9099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number07350078030090 UDI-DIDate16 Sep 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number7350078030090WK Basic UDI-DIDate20 Feb 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
Redsense FOE EUDAMED
Redsense Fiber Optic Extension GUDID
Generic Name
Intravenous access site monitoring system fibreoptic cable, reusable
Device Name
Redsense Alarm fiber optic extension (FOE)
Model / Ref / Catalog
Redsense Alarm fiber optic extension (FOE), RE-1-RE201, 1
Primary DI / UDI-DI
07350078030090, 07350078030441
Basic UDI-DI
7350078030090WK, 7350078030441WS
Direct Marketing DI
07350078030090
07350078030441
510(k) Number
FDA Product Code
ODX
EMDN Code
F9099 Dialysis devices - other
GMDN Term
Intravenous access site monitoring system fibreoptic cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5820
Market of Registration
Netherlands
Germany
Commercial Distribution
In Commercial Distribution
Size
Length — 2 Meter
Outer Diameter — 15 Millimeter
Weight — 32 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Redsense Alarm fiber optic extension (FOE)
RE-1-RE201
GUDID
1
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
SE-MF-000005240

Other devices from Redsense Medical AB

See all devices from Redsense Medical AB →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (21)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 05627583-360d-4066-91c2-0bc31cbb9be9 61 fields · synced 22 Oct 2026
  • EUDAMED 07350078030441|7350078030441WS 61 fields · synced 5 Oct 2026
  • FDA UDI 0b689c0d-d081-4050-ba84-c8c459dd557e 38 fields · synced 22 Oct 2026