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Lower limb brace

by Neotech Care Inc. 57 variants

Ref NTC_011AN Beige XL_2P_NPModel NTC-005CA, NTC-006AN, NTC-010KN, NTC-011AN, NTC-014KN, NTC-016AN, NTC-022LE, NTC-LL01, NTC-LL02, NTC-LL03

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00843776104486 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08437761Lowerlimbbrace7K Basic UDI-DI 00843776104486UDI-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  • Withdrawn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
Ankle/foot orthosis
Device Name
Lower limb brace
Model / Reference
NTC-005CA EUDAMED
NTC-006AN EUDAMED
NTC-010KN EUDAMED
NTC-011AN EUDAMED
NTC-014KN EUDAMED
NTC-016AN EUDAMED
NTC-022LE EUDAMED
NTC-LL01 EUDAMED
NTC-LL02 EUDAMED
NTC-LL03 EUDAMED
NTC_011AN Beige XL_2P_NP EUDAMED
NTC_011AN Beige XL_2PC GUDID
Primary DI / UDI-DI
00843776104486
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

Manufacturer details

EUDAMED SRN
US-MF-000054164
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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