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Dynamic Femur Fracture Brace NS-DF2B-0005

by Orthopediatrics Corp.

Ref NS-DF2B-0005Model NS-DF2B-0001

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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
European UnionCE/MDR EUDAMED Number08411321DF25000PEJV Basic UDI-DI 00840194462891UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840194462891 UDI-DI Date25 Jun 2023ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
OrthoPediatrics® Dynamic Femur Fracture (DF2) Brace EUDAMED
Dynamic Femur Fracture Brace GUDID
Generic Name
Multiple-joint lower limb orthosis
Model / Ref / Catalog
NS-DF2B-0005, NS-DF2B-0001
Primary DI / UDI-DI
00840194462891
Basic UDI-DI
08411321DF25000PEJV
FDA Product Code
IQI
EMDN Code
Y061216 Hip-knee orthoses
GMDN Term
Multiple-joint lower limb orthosis
Device Class
Class I
Regulation Number
890.3475
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No