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Lower limb brace

by Neotech Care Inc. 57 variants

Ref NTC_005CA XL_2PCModel 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 Number00843776102550 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08437761Lowerlimbbrace7K Basic UDI-DI 00843776102550UDI-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  • Withdrawn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
Multiple-joint lower limb orthosis
Device Name
Lower limb brace
Model / Reference
NTC-005CA, NTC-006AN, NTC-010KN, NTC-011AN, NTC-014KN, NTC-016AN, NTC-022LE, NTC-LL01, NTC-LL02, NTC-LL03, NTC_005CA XL_2PC
Primary DI / UDI-DI
00843776102550
Basic UDI-DI
08437761Lowerlimbbrace7K
FDA Product Code
IQI
EMDN Code
Y061299 Lower extremity orthoses - other
GMDN Term
Multiple-joint lower limb 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