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ErGO-Scan 7300 Sensor

by Tekscan, Inc.

Ref 7300-5Model TekDAQ-200

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, self-declared

Class I: no certifier involved

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/MDR EUDAMED Number++B970TD200XM Basic UDI-DI B970730050UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB970730050 UDI-DI Date4 Aug 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
ErGO-Scan EUDAMED
ErGO-Scan 7300 Sensor GUDID
Generic Name
Body-surface pressure mapping system
Model / Ref / Catalog
TekDAQ-200, 7300-5, ErGO-Scan 7300 Sensor
Primary DI / UDI-DI
B970730050
Basic UDI-DI
++B970TD200XM
Direct Marketing DI
*+B970730050/*
FDA Product Code
JFC
EMDN Code
Z12062603 Sensor-based platforms
GMDN Term
Body-surface pressure mapping system
Device Class
Class I
Regulation Number
890.1600
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TekDAQ-200
7300-5
GUDID
ErGO-Scan 7300 Sensor

Other devices from Tekscan, Inc.

See all devices from Tekscan, Inc. →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No