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Eva Scalp Cooling System EVACCK 1

by Stemtech Medical Devices Private Limited 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number89080300020134 UDI-DI Date4 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Eva Scalp Cooling System
Generic Name
Scalp cooling system, hair loss
Model / Reference
EVACCK 1
Description
Eva Cool Cap Kit Contents: EvaCool SmartFit Cool Wrap - 1 unit Eva Insulation Cap - 1 unit EvaCool Coolant Bottle - 1 unit Cotton Headband - 1 unit
Primary DI / UDI-DI
89080300020134
510(k) Number
FDA Product Code
PMC
GMDN Term
Scalp cooling system, hair loss
Device Class
Class II
Regulation Number
878.4360
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K252289)

Other devices from Stemtech Medical Devices Private Limited

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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