Skip to content

ivWatch Fiber Optic Sensor Cable

by ivWatch, LLC

Ref AC-1001000Model Model 400

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

CE MDR

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/MDR EUDAMED Number081408802AC-1001000JP Basic UDI-DI 00814088020047UDI-DIDate24 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number00814088020047 UDI-DI Date14 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
ivWatch Fiber Optic Sensor Cable EUDAMED
ivWatch Sensor Cable GUDID
Generic Name
Intravenous access site monitoring system fibreoptic cable, reusable
Model / Reference
Model 400, AC-1001000
Primary DI / UDI-DI
00814088020047
Basic UDI-DI
081408802AC-1001000JP
Direct Marketing DI
00814088020047
FDA Product Code
PMS
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Intravenous access site monitoring system fibreoptic cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
880.5725
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 118.1 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000001531
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from Ivwatch, LLC

See all devices from Ivwatch, LLC →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No