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Thermoflect Blanket

by Encompass Group, LLC United States EUDAMEDGUDID

Ref 5100-400Model 5100-200 Product code KMEEMDN T030399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-30612899510402 Basic UDI-DIDate21 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number30612899510402 UDI-DIDate8 Sep 2022ListedStatusWithdrawn

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Withdrawn
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Thermoflect Blanket EUDAMED
Thermoflect GUDID
Generic Name
Hypothermia-prevention whole-body suit
Device Name
Thermoflect Blanket, Medium
Model / Reference
5100-400, 5100-200
Primary DI / UDI-DI
30612899510402
Basic UDI-DI
B-30612899510402, 0612899THERMOFLECT6X
FDA Product Code
KME
EMDN Code
T030399 Heating covers - other
GMDN Term
Hypothermia-prevention whole-body suit
Device Class
Class I
Regulation Number
880.6060
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
US-MF-000008638
Authorised representative
The Surgical Company International B.V. NL-AR-000001974

Other devices from Encompass Group, LLC

See all devices from Encompass Group, LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date
Other properties (19)
  • 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
  • Serial Number: No
  • Expiration Date: No

Sources (3)

  • EUDAMED 95ac3e86-e6a7-4f36-bbf6-e7aa86c9108a 61 fields · synced 24 Oct 2026
  • FDA UDI 1c745cd1-cd64-4b78-9aac-da1564a10cbc 34 fields · synced 30 May 2026
  • EUDAMED 30612899510402|0612899THERMOFLECT6X 61 fields · synced 9 Oct 2026