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Neotech Care NTC022IB-BLU9

by Neotech Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref NTC022IB-BLU9-SLModel 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 Number00843776103274 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
NTC-IB-BLU6 EUDAMED
NTC-IB-BLU9 EUDAMED
NTC-IB-BLU12 EUDAMED
NTC-IB-LIM6 EUDAMED
NTC-IB-LIM9 EUDAMED
NTC-IB-LIM12 EUDAMED
NTC-IB-HEA6 EUDAMED
NTC-IB-HEA9 EUDAMED
NTC-IB-HEA12 EUDAMED
NTC-IB-ANI6 EUDAMED
NTC-IB-ANI9 EUDAMED
NTC-IB-ANI12 EUDAMED
NTC-IB-BAL6 EUDAMED
NTC-IB-BAL9 EUDAMED
NTC-IB-BAL12 EUDAMED
NTC-IB-BAN6 EUDAMED
etc. EUDAMED
NTC022IB-BLU9-SL EUDAMED
NTC022IB-BLU9 GUDID
Primary DI / UDI-DI
00843776103274
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