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Thermoflect Cap

by Encompass Group, LLC United States EUDAMEDGUDID

Ref 5110-100Model 5100-200 Product code FMEEMDN T030399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-30612899511102 Basic UDI-DIDate21 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market
European UnionCE/MDD EUDAMED NumberB-30612899511102 Basic UDI-DIDate21 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number30612899511102 UDI-DIDate27 Oct 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/MDR, 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 Cap EUDAMED
Thermoflect GUDID
Generic Name
Hypothermia-prevention cap
Device Name
Thermoflect Cap, Adult
Thermoflect Blanket
Model / Reference
5110-100, 5100-200
Primary DI / UDI-DI
30612899511102
Basic UDI-DI
B-30612899511102, 0612899THERMOFLECT6X
FDA Product Code
FME
EMDN Code
T030399 Heating covers - other
GMDN Term
Hypothermia-prevention cap
Device Class
Class I
Regulation Number
880.6265
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 94d1310f-06ec-4827-b158-c37c841f3f43 61 fields · synced 22 Oct 2026
  • FDA UDI 28255486-f8b9-42bb-b63f-c89041032114 34 fields · synced 30 May 2026
  • EUDAMED 30612899511102|0612899THERMOFLECT6X 61 fields · synced 24 Oct 2026