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DINAMIC T HUMERUS ø7mmx200mm handle for scalpel

by Citieffe

Part of a family of 26 devices: see the family page

Ref 4048Model Handle

DINAMIC T HUMERUS ø7mmx200mm handle for scalpel (4048) is a device classified as Class I in the EU and Class II in the US made by Citieffe, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI 803290962159CF), cleared under FDA 510(k) K113387 on 15 Mar 2012 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08032909625840), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K113387

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962159CF Basic UDI-DI 08032909625840UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909625840 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK113387 Date15 Mar 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962159CF registered 16 Sep 2026 Active
  • FDA 510(k) K113387 decided 15 Mar 2012 Active
  • FDA GUDID UDI-DI 08032909625840 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K113387
  2. Listed FDA GUDID 08032909625840
  3. Registered EUDAMED 803290962159CF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Surgical Instruments (I) EUDAMED
Dinamic T Humerus GUDID
Generic name
Scalpel handle, reusable
Model / Ref / Catalog
Handle, 4048, ø7mmx200mm handle for scalpel
Primary DI / UDI-DI
08032909625840
Basic UDI-DI
803290962159CF
Direct marketing DI
08032909625840
510(k) Number
FDA product code
HSB
EMDN code
L010103 Handles for scalpels, reusable
GMDN term
Scalpel handle, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Handle
4048
GUDID
ø7mmx200mm handle for scalpel
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Scalpel handle, reusable

Cleared under the same submission (K113387)

and 8 more cleared under K113387

Similar devices in this category

Other devices filed under HANDLES FOR SCALPELS, REUSABLE.

Other devices from Citieffe

See all devices from Citieffe →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)