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ROTEM® sigma ROTROL N

by Tem Innovations GmbH

ROTEM® sigma ROTROL N (555201) is a Class II device made by Tem Innovations GmbH, listed in FDA GUDID since 4 Oct 2022 (UDI-DI 04260160470341), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260160470341 UDI-DI Date4 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Rotem®
Generic name
Multiple coagulation marker IVD, control
Model / Ref / Catalog
sigma ROTROL N, 555201
Primary DI / UDI-DI
04260160470341
FDA product code
JPA
GMDN term
Multiple coagulation marker IVD, control
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple coagulation factor IVD, control

Similar devices in this category

Other devices filed under Multiple coagulation factor IVD, control.

Other devices from Tem Innovations GmbH

  • ROTEM® in-tem®

    Class II

  • ROTEM® ap-tem®

    Class II

  • Rotem® Rotrol N

    Class II

  • ROTEM® sigma complete + hep

    Class II

See all devices from Tem Innovations GmbH →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)