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ivWatch Extension Module

by ivWatch, LLC

Ref AE-1001003Model Model 400

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

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number081408802AE-1001003LB Basic UDI-DI 00814088020122UDI-DIDate29 Aug 2025RegisteredStatusActive
European UnionCE/MDR EUDAMED Number081408802AE-1001003LB Basic UDI-DI 00814088020122UDI-DIDate29 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00814088020122 UDI-DI Date17 Jul 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 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Intravenous access site infiltration/extravasation monitoring system transceiver
Model / Ref / Catalog
Model 400, AE-1001003, 00814088020122
Primary DI / UDI-DI
00814088020122
Basic UDI-DI
081408802AE-1001003LB, B-00814088020122
Direct Marketing DI
00814088020122
FDA Product Code
PMS
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
GMDN Term
Intravenous access site infiltration/extravasation monitoring system transceiver
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5725
EU market of registration
Netherlands
Italy
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Weight — 0.46 Pound
Depth — 3.8 Inch
Width — 5.9 Inch
Length — 4.1 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Other devices from Ivwatch, LLC

See all devices from Ivwatch, LLC →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing 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
  • Lot / Batch Number: No
  • Expiration Date: No