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ROTEM® sigma complete + hep

by Tem Innovations GmbH

ROTEM® sigma complete + hep (555502) is a Class II device made by Tem Innovations GmbH, cleared under FDA 510(k) K201440 on 8 Jul 2022 and listed in FDA GUDID since 4 Oct 2022 (UDI-DI 04260160470327), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K201440

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260160470327 UDI-DI Date4 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201440 Date8 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201440 decided 8 Jul 2022 Active
  • FDA GUDID UDI-DI 04260160470327 listed 4 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201440
  2. Listed FDA GUDID 04260160470327

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rotem®
Generic name
Multiple coagulation marker IVD, kit, clotting
Model / Ref / Catalog
sigma complete + hep, 555502
Primary DI / UDI-DI
04260160470327
510(k) Number
FDA product code
JPA
GMDN term
Multiple coagulation marker IVD, kit, clotting
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple coagulation factor IVD, kit, clotting

Similar devices

Other devices filed under FDA product code JPA (System, Multipurpose For In Vitro Coagulation Studies).

Other devices from Tem Innovations GmbH

See all devices from Tem Innovations GmbH →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)