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Tel-O-Graph GSM Plus

by IEM GmbH Germany EUDAMEDGUDID

Ref 030100001, 030100010Model Tel-O-Graph GSM Plus

Product code DXNEMDN Z1203020302

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4041346102272X Basic UDI-DIDate4 Jul 2025RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number04041346101262 UDI-DIDate20 Jan 2022ListedStatusWithdrawn

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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Tel-O-Graph GSM Plus EUDAMED
Tel-O-Graph GSM Plus (LTE) EUDAMED
Tel-O-Graph GUDID
Generic Name
Telemetric sphygmomanometer
Model / Reference
Tel-O-Graph GSM Plus EUDAMED
030100001 EUDAMED
030100010 EUDAMED
GSM plus GUDID
Primary DI / UDI-DI
04041346101262, 04041346102160
Basic UDI-DI
4041346102272X
Direct Marketing DI
04041346101262
04041346102160
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Telemetric sphygmomanometer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1130
Market of Registration
Germany
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Tel-O-Graph GSM Plus
030100001
030100010
GUDID
GSM plus
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000005735

Other devices from IEM GmbH

See all devices from IEM GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
  • Prescription Use
  • 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
  • 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

Sources (4)

  • EUDAMED 4075446d-5d61-4fd3-9853-50a0e3d53e09 61 fields · synced 24 Oct 2026
  • EUDAMED 04041346102160|4041346102272X 61 fields · synced 19 May 2026
  • FDA UDI bc2bc7d2-5502-447b-adb9-0b8cd8834c11 33 fields · synced 29 May 2026
  • FDA UDI 65b6c63d-d50d-45a0-8ef3-2e9303bb1616 34 fields · synced 30 May 2026