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Dermadry - Total - EN/FR/DE/SP/IT/NL Europe

by Dermadry Laboratories Inc.

Ref FPRD-052Model Dermadry - Total - EN/FR/DE/SP/IT/NL Europe

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number87706700DERMADRY58 Basic UDI-DI 00877067000256UDI-DIDate4 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00877067000256 UDI-DI Date17 Mar 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
Dermadry - Total - EN/FR/DE/SP/IT/NL Europe EUDAMED
Dermadry GUDID
Generic Name
Hyperhidrosis iontophoresis system
Model / Ref / Catalog
Dermadry - Total - EN/FR/DE/SP/IT/NL Europe EUDAMED
FPRD-052 EUDAMED
TOTAL GUDID
FPRD-004 GUDID
Primary DI / UDI-DI
00877067000256
Basic UDI-DI
87706700DERMADRY58
510(k) Number
FDA Product Code
EGJ
EMDN Code
Z120604 Iontophoresis equipment
GMDN Term
Hyperhidrosis iontophoresis system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.5525
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Dermadry - Total - EN/FR/DE/SP/IT/NL Europe
FPRD-052
GUDID
TOTAL
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CA-MF-000025789
Authorised representative
CEpartner4U NL-AR-000000111

Other devices from Dermadry Laboratories Inc.

See all devices from Dermadry Laboratories Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No