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Snuggle Warm Upper Body Convective Warming Blanket

by ICU Medical, Inc.

Ref SWU-2003

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, self-declared

Class I: no certifier involved

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 Number0610586M0079DK Basic UDI-DI 10610586043345UDI-DIDate4 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10610586043345 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Snuggle Warm Upper Body Convective Warming Blanket EUDAMED
Level 1 GUDID
Generic Name
External circulating-air core temperature regulation system pad, single-use
Device Name
Snuggle Warm Patient Warming Blankets
Model / Reference
SWU-2003
Primary DI / UDI-DI
10610586043345
Basic UDI-DI
0610586M0079DK
510(k) Number
FDA Product Code
DWJ
EMDN Code
Z12040208 Body thermoregulation equipment
GMDN Term
External circulating-air core temperature regulation system pad, single-use
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.5900
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002566
Authorised representative
ICU Medical BV NL-AR-000002748

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: 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
  • Serial Number: No
  • Manufacturing Date: No