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BioStamp nPoint™ MC-0012

by MC10, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 NumberB493MC0012 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: not 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  • Withdrawn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
BioStamp nPoint™
Generic Name
Kinesiology/electromyographic sensor set
Model / Reference
MC-0012
Primary DI / UDI-DI
B493MC0012
FDA Product Code
MWI, LEL, IKN, DRG
GMDN Term
Kinesiology/electromyographic sensor set
Device Class
Class II
Regulation Number
870.2300, 882.5050, 890.1375, 870.2910
GUDID distribution status
Not in Commercial Distribution

Other devices from MC10, Inc.

Properties

  • Prescription Use
  • Convenience Kit

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No