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Extender Manual

by B.T.I. Biotechnology Institute, S.l 12 variants

Ref INEAE15

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84353898EXTENSORSG Basic UDI-DI 08435389825920UDI-DIDate20 Aug 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08435389825920 UDI-DI Date21 May 2024ListedStatusListed 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.

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  • Withdrawn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
Implant Extension; Interna Narrow; 15mm
Generic Name
Orthopaedic implant-instrument extension adaptor, reusable
Device Name
Extender Manual
Model / Reference
INEAE15
Primary DI / UDI-DI
08435389825920
Basic UDI-DI
84353898EXTENSORSG
Direct Marketing DI
08435389825920
FDA Product Code
NDP
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Orthopaedic implant-instrument extension adaptor, reusable
Device Class
Class I
Regulation Number
872.3980
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

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
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No