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Neotech Care NTCY001_L

by Neotech Care Inc.

Ref NTCY001M_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

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776105964 UDI-DIDate14 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08437761UpperlimbbraceCU Basic UDI-DIDate18 May 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  • Withdrawn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
Lumbar spine orthosis
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
NTCY001M_L EUDAMED
NTCY001_L GUDID
Primary DI / UDI-DI
00843776105964
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
GUDID distribution status
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