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TargetCool-e RH-PD06W

by RecensMedical, Inc.

Ref RH-PD06WModel RM-DT02W

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

21 Nov 2030

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier 3EC International a.s.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2025-MDR/QS-057/B Date31 Jul 2026IssuedStatusActive expires 21 Nov 2030
United StatesGUDID listing GUDID Number08800073100148 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2025-MDR/QS-057/B Active Amended

    Quality management system EU MDR

    Certifier
    3EC International a.s. 2265
    Issued
    31 Jul 2026
    Expires
    21 Nov 2030
    Reason
    Mnf data change

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
TargetCool-e
Generic Name
General cryosurgical system, cryogen gas, mechanical
Model / Reference
RH-PD06W, RM-DT02W
Primary DI / UDI-DI
08800073100148
Basic UDI-DI
88000731RM-DT02WJP
510(k) Number
FDA Product Code
GEH
EMDN Code
M9001 Cryotherapy and thermotherapy devices
GMDN Term
General cryosurgical system, cryogen gas, mechanical
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
878.4350
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from RecensMedical, Inc.

  • OcuCool ODM-E01

    Not classified

  • OcuCool

    Not classified

  • CryoVIVE

    Class II

  • TargetCool (RM-DT02W)

    Class IIa

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No