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Neotech Care NTCY001M_Grey_L

by Neotech Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref NTCY001M_Grey_LModel 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 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776103021 UDI-DIDate14 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 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Neotech Care
Generic Name
Lumbar spine orthosis
Device Name
Upper limb brace
Model / Reference
NTCY001M_Grey_L, 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
Primary DI / UDI-DI
00843776103021
Basic UDI-DI
08437761UpperlimbbraceCU
FDA Product Code
IQE
EMDN Code
Y060699 Orthoses, upper extremity - other
GMDN Term
Lumbar spine orthosis
Device Class
Class I
Regulation Number
890.3490
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

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