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Non sterile ice packs

by Neotech Care Inc. 22 variants

Ref NTC023IB-STR12Model 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.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

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
United StatesGUDID listing GUDID Number00843776102000 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08437761IcePacks4S Basic UDI-DI 00843776102000UDI-DIDate16 Jun 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Neotech Care
Generic Name
Ice bag
Device Name
Non sterile ice packs
Model / Reference
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., NTC023IB-STR12
Primary DI / UDI-DI
00843776102000
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
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
US-MF-000054164
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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