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Comfort Marker 2.0.

by Medical Precision BV De Novo

Active United States

De Novo DEN200041

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN200041 Date10 Dec 2021DecidedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

De Novo

De Novo Number
FDA Product Code
QRN
Device Class
Class II
Regulation
21 CFR Part 892.5785
Advisory Committee
Radiology
FDA Decision
DENG De Novo granted

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