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BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables BT-201

by Bioptimal International Pte. Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08886483507005 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
BIOTRANS™ Reusable Sensor Base and Monitor Adapter Cables
Generic Name
Invasive-pressure external transducer, reusable
Model / Ref / Catalog
BT-201, BL-0003-018
Primary DI / UDI-DI
08886483507005
FDA Product Code
DRS
GMDN Term
Invasive-pressure external transducer, reusable
Device Class
Class II
Regulation Number
870.2850
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No