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Neotech Care NTC023IB-STR9

by Neotech Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref NTC023IB-STR9Model NTC-IB-BLU6, NTC-IB-BLU9, NTC-IB-BLU12, NTC-IB-LIM6, NTC-IB-LIM9, NTC-IB-LIM12, NTC-IB-HEA6, NTC-IB-HEA9, NTC-IB-HEA12, NTC-IB-ANI6, NTC-IB-ANI9, NTC-IB-ANI12, NTC-IB-BAL6, NTC-IB-BAL9, NTC-IB-BAL12, NTC-IB-BAN6, etc.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776101997 UDI-DIDate23 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08437761IcePacks4S Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

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 Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Neotech Care
Generic Name
Ice bag
Device Name
Non sterile ice packs
Model / Reference
NTC023IB-STR9, NTC-IB-BLU6, NTC-IB-BLU9, NTC-IB-BLU12, NTC-IB-LIM6, NTC-IB-LIM9, NTC-IB-LIM12, NTC-IB-HEA6, NTC-IB-HEA9, NTC-IB-HEA12, NTC-IB-ANI6, NTC-IB-ANI9, NTC-IB-ANI12, NTC-IB-BAL6, NTC-IB-BAL9, NTC-IB-BAL12, NTC-IB-BAN6, etc.
Primary DI / UDI-DI
00843776101997
Basic UDI-DI
08437761IcePacks4S
FDA Product Code
KYR
EMDN Code
M9001 Cryotherapy and thermotherapy devices
GMDN Term
Ice bag
Device Class
Class I
Regulation Number
880.6050
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Neotech Care Inc.

See all devices from Neotech Care Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (22)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No