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Neotech Care NTC-U010N XXL

by Neotech Care Inc.

Ref NTC-U010N XXLModel 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776106084 UDI-DIDate23 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  • Withdrawn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-U010N XXL, 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
00843776106084
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
Belgium
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