Skip to content

Wiemspro

by Medical Cables, Inc.

Ref SEU530PS10DB7

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 7 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 7 Oct 2026. What this means

Regulatory status

as of registry sync 7 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08435393716450 Basic UDI-DI 08435393716450UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435393716450 UDI-DI Date15 May 2019ListedStatusListed 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 7 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
SpO2 Sensor Medical Cables EUDAMED
Wiemspro GUDID
Generic Name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Name
SpO2 Sensor
Model / Reference
SEU530PS10DB7 EUDAMED
WIEMSPRO GUDID
Primary DI / UDI-DI
08435393716450
Basic UDI-DI
B-08435393716450
510(k) Number
FDA Product Code
NGX
EMDN Code
Z12030285 Vital signs monitoring instruments - consumables
GMDN Term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
890.5850
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SEU530PS10DB7
GUDID
WIEMSPRO
Device ClassEUDAMED
Class IIb
GUDID
Class II

Other devices from Medical Cables, Inc.

Properties

  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No