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Upper limb brace

by Neotech Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref NTCT007 Ivory MModel NTC-T007, NTC-T004, NTC-T001, NTC-T002, NTC-T008, NTC-MPM001, NTC-PM001, NTC-PM002, NTC-U010N, NTC-Y015, NTC-Y001, NTC-Y003, NTC-U023, NTC-U086, NTC-U045, NTC-B011, NTC-B012, NTC-B013, NTC-B014, NTC-001WR, NTC-007WR, NTC-008PA, NTC-009EL, NTC-012WR, etc

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776102246 UDI-DIDate22 Jul 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number08437761UpperlimbbraceCU Basic UDI-DIDate18 May 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 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Neotech Care
Generic Name
Abdominal binder, reusable
Device Name
Upper limb brace
Model / Reference
NTC-T007 EUDAMED
NTC-T004 EUDAMED
NTC-T001 EUDAMED
NTC-T002 EUDAMED
NTC-T008 EUDAMED
NTC-MPM001 EUDAMED
NTC-PM001 EUDAMED
NTC-PM002 EUDAMED
NTC-U010N EUDAMED
NTC-Y015 EUDAMED
NTC-Y001 EUDAMED
NTC-Y003 EUDAMED
NTC-U023 EUDAMED
NTC-U086 EUDAMED
NTC-U045 EUDAMED
NTC-B011 EUDAMED
NTC-B012 EUDAMED
NTC-B013 EUDAMED
NTC-B014 EUDAMED
NTC-001WR EUDAMED
NTC-007WR EUDAMED
NTC-008PA EUDAMED
NTC-009EL EUDAMED
NTC-012WR EUDAMED
etc EUDAMED
NTCT007 Ivory M EUDAMED
NTCT007_Ivory_M GUDID
Primary DI / UDI-DI
00843776102246
Basic UDI-DI
08437761UpperlimbbraceCU
FDA Product Code
ISR
EMDN Code
Y060699 Orthoses, upper extremity - other
GMDN Term
Abdominal binder, reusable
Device Class
Class I
Regulation Number
890.3025
Market of Registration
France
Commercial Distribution
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