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Nice NICE1

by Nice Recovery Systems, LLC

Ref 4002, 4004

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 Number08621030003400X3Y Basic UDI-DI 00862103000307UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00862103000307 UDI-DI Date15 Sep 2016ListedStatusListed 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  • Withdrawn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
NICE1 EUDAMED
Nice GUDID
Generic Name
Circulating-fluid localized thermal therapy system pack, reusable
Device Name
NICE1 System
Model / Reference
4002 EUDAMED
4004 EUDAMED
NICE1 GUDID
Primary DI / UDI-DI
00862103000307
Basic UDI-DI
08621030003400X3Y
510(k) Number
FDA Product Code
ILO, IRP
EMDN Code
M9001, Z120607
GMDN Term
Circulating-fluid localized thermal therapy system pack, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
890.5720, 890.5650
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
4002, 4004
GUDID
NICE1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Nice Recovery Systems, LLC

See all devices from Nice Recovery Systems, LLC →

Properties

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

Other properties (19)

  • 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