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Neotech Care NTC_006AN Grey M_2PC

by Neotech Care Inc. EUDAMEDGUDID

Active European Union

Ref NTC_006AN Grey M_2PCModel NTC-005CA, NTC-006AN, NTC-010KN, NTC-011AN, NTC-014KN, NTC-016AN, NTC-022LE, NTC-LL01, NTC-LL02, NTC-LL03

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776103854 UDI-DIDate11 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08437761Lowerlimbbrace7K Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Neotech Care
Generic Name
Ankle/foot orthosis
Device Name
Lower limb brace
Model / Reference
NTC_006AN Grey M_2PC, NTC-005CA, NTC-006AN, NTC-010KN, NTC-011AN, NTC-014KN, NTC-016AN, NTC-022LE, NTC-LL01, NTC-LL02, NTC-LL03
Primary DI / UDI-DI
00843776103854
Basic UDI-DI
08437761Lowerlimbbrace7K
FDA Product Code
ITW
EMDN Code
Y06120601 Passive ankle-foot orthoses
GMDN Term
Ankle/foot orthosis
Device Class
Class I
Regulation Number
890.3475
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