Skip to content

Instrument Rack

by B.T.I. Biotechnology Institute, S.l 3 variants

Ref FFXS

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08435389830276 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number84353898AUX-INSTRACKJ9 Basic UDI-DI Date20 Oct 2025RegisteredStatusActive

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  • Withdrawn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
Drill Holder for Extra Short Drills
Generic Name
Surgical instrument/implant rack
Device Name
Instrument Rack
Model / Reference
FFXS
Primary DI / UDI-DI
08435389830276, 08435389830962
Basic UDI-DI
84353898AUX-INSTRACKJ9
Direct Marketing DI
08435389830276
08435389830962
FDA Product Code
FSM
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Surgical instrument/implant rack
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
ES-MF-000001701

Related devices

Category: Device sterilization/disinfection container, reusable

Other devices from B.T.I. Biotechnology Institute, S.l

See all devices from B.T.I. Biotechnology Institute, S.l →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

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