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SBPM cuff size M

by IEM GmbH

Ref 04041346101217Model HBPM Cuff

SBPM cuff size M is a device classified as Class I in the EU and Class II in the US made by IEM GmbH, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 40413461009536), cleared under FDA 510(k) K173895 on 16 May 2019 and listed in FDA GUDID since 20 Jan 2022 (UDI-DI 04041346101217), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173895

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40413461009536 Basic UDI-DI 04041346101217UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04041346101217 UDI-DI Date20 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173895 Date16 May 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 40413461009536 registered 19 May 2026 Active
  • FDA 510(k) K173895 decided 16 May 2019 Active
  • FDA GUDID UDI-DI 04041346101217 listed 20 Jan 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173895
  2. Listed FDA GUDID 04041346101217
  3. Registered EUDAMED 40413461009536

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Tel-O-Graph® Manschette M EUDAMED
SBPM cuff GUDID
Generic name
Telemetric sphygmomanometer
Device name
HBPM Cuff
Model / reference
HBPM Cuff EUDAMED
04041346101217 EUDAMED
size M GUDID
Primary DI / UDI-DI
04041346101217
Basic UDI-DI
40413461009536
Direct marketing DI
04041346101217
510(k) Number
FDA product code
DXN
EMDN code
Z1203020685 Vital signs telemetry instruments - consumables
GMDN term
Telemetric sphygmomanometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1130
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HBPM Cuff
04041346101217
GUDID
size M
Device classEUDAMED
Class I
GUDID
Class II
Contains latexEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Contains latex UDI-DI 04041346101217: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Telemetric sphygmomanometer

Cleared under the same submission (K173895)

Similar devices in this category

Other devices filed under VITAL SIGNS TELEMETRY INSTRUMENTS (ECG, NIPB, EtCO2, SpO2, RESPIRATION,...).

Other devices from IEM GmbH

See all devices from IEM GmbH →

Properties

  • Contains latex YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)