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TargetCool RM-DC04U

by RecensMedical, Inc.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800073100049 UDI-DI Date29 Nov 2022ListedStatusListed GUDID: not in commercial distribution
European UnionCE/MDD EUDAMED Number— Date—StatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
TargetCool
Generic Name
General cryosurgical system, cryogen gas, mechanical
Model / Reference
RM-DC04U
Primary DI / UDI-DI
08800073100049
FDA Product Code
GEH, MLY
GMDN Term
General cryosurgical system, cryogen gas, mechanical
Device Class
Class II
Regulation Number
878.4350
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: General cryosurgical system, cryogen gas, mechanical

Other devices from RecensMedical, Inc.

  • TargetCool-e RH-PD06W

    Class II

  • OcuCool ODM-E01

    Not classified

  • OcuCool

    Not classified

  • CryoVIVE

    Class II

  • TargetCool (RM-DT02W)

    Class IIa

Properties

  • Single Use
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No