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Cardioskin Textile S30 1005-00007-US

by Bioserenity Medical Devices Group United States GUDID

Product code DRX

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03615220001057 UDI-DIDate22 Jan 2019ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
Cardioskin Textile S30
Generic Name
Electrocardiograph, home-use
Model / Ref / Catalog
1005-00007-US
Primary DI / UDI-DI
03615220001057
FDA Product Code
DRX
GMDN Term
Electrocardiograph, home-use
Device Class
Class II
Regulation Number
870.2360
Commercial Distribution
Not in Commercial Distribution

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (10)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (1)

  • FDA UDI 1b3112e6-6ba1-45ff-ab77-083176f6ac93 35 fields · synced 22 Oct 2026