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Dyna Locking Trochanteric Nail™

by CG MedTech Co., Ltd. 184 variants

Ref 32064

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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
European UnionCE/MDD EUDAMED NumberB-08800015936941 Basic UDI-DI 08800015936941UDI-DIDate27 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800015936941 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

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 found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Dyna Locking Trochanteric Nail™ EUDAMED
Dyna Locking IM Nail GUDID
Generic Name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Name
LOCKING SCREW - 5.0 X 40 mm
Model / Reference
32064
Primary DI / UDI-DI
08800015936941
Basic UDI-DI
B-08800015936941
510(k) Number
FDA Product Code
HSB
EMDN Code
P09120201 Intramedullary nails
GMDN Term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3020
EU market of registration
Greece
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
KR-MF-000035461
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Arthrodesis intramedullary nail, non-distracting

Other devices from CG MedTech Co., Ltd.

See all devices from CG MedTech Co., Ltd. →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (17)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No