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Neotech Care NTC_020WR M_2PC

by Neotech Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref NTC_020WRa M_2PCModel 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 Number00843776101249 UDI-DIDate11 Sep 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
Wrist 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
NTC_020WRa M_2PC EUDAMED
NTC_020WR M_2PC GUDID
Primary DI / UDI-DI
00843776101249
Basic UDI-DI
08437761UpperlimbbraceCU
FDA Product Code
NOC
EMDN Code
Y060609 Wrist (forearm) orthoses
GMDN Term
Wrist binder, reusable
Device Class
Class I
Regulation Number
878.3910
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Contains LatexEUDAMED
Yes
GUDID
No

Other devices from Neotech Care Inc.

See all devices from Neotech Care Inc. →

Properties

  • Contains Latex YesEUDAMEDNoGUDID
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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