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DOLPHIX Box

by Citieffe

Ref DF900300Model Box

DOLPHIX Box (DF900300) 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 803290962155C7), cleared under FDA 510(k) K132363 on 16 Jan 2014 and listed in FDA GUDID since 29 Sep 2016 (UDI-DI 08032909625338), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132363

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803290962155C7 Basic UDI-DI 08032909625338UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08032909625338 UDI-DI Date29 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132363 Date16 Jan 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803290962155C7 registered 16 Sep 2026 Active
  • FDA 510(k) K132363 decided 16 Jan 2014 Active
  • FDA GUDID UDI-DI 08032909625338 listed 29 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132363
  2. Listed FDA GUDID 08032909625338
  3. Registered EUDAMED 803290962155C7

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  • Withdrawn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
Dolphix GUDID
Generic name
Pass-through cabinet
Model / Ref / Catalog
Box, DF900300
Primary DI / UDI-DI
08032909625338
Basic UDI-DI
803290962155C7
Direct marketing DI
08032909625338
510(k) Number
FDA product code
JDW, KTT
EMDN code
V0499 Clinical use containers (non-IVD) - other
GMDN term
Pass-through cabinet
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3040, 888.3030
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 08032909625338: EUDAMED states Yes, FDA GUDID states No.

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: Pass-through cabinet

Cleared under the same submission (K132363)

and 8 more cleared under K132363

Similar devices

Also classified as Pass-through cabinet.

Similar devices in this category

Other devices filed under CLINICAL USE CONTAINERS (NON-IVD).

Other devices from Citieffe

See all devices from Citieffe →

Properties

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