Skip to content

The Insides Neo

by The Insides Company Limited United States EUDAMEDGUDID

Ref PS013, PS031

Product code EXBEMDN G99

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09421905447133 UDI-DIDate16 Oct 2025ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number09421905447CHYMEIIJL Basic UDI-DIDate17 Dec 2023RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Generic Name
ENFit/ENFit linear connector
Model / Reference
PS013, PS031
Primary DI / UDI-DI
09421905447133, 09421905447225
Basic UDI-DI
09421905447CHYMEIIJL
FDA Product Code
EXB
EMDN Code
G99 Gastrointestinal devices - other
GMDN Term
ENFit/ENFit linear connector
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
876.5900
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
NZ-MF-000011306
Authorised representative
Advena Limited MT-AR-000000234

Other devices from The Insides Company Limited

See all devices from The Insides Company Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (15)
  • Implantable: No
  • Reusable: 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

Sources (3)

  • EUDAMED 1c844a86-6ec4-44c0-bc14-17ee353ca5c6 61 fields · synced 22 Oct 2026
  • EUDAMED 09421905447225|09421905447CHYMEIIJL 61 fields · synced 19 May 2026
  • FDA UDI 286b5e8e-c740-46cd-b5cf-d302bba27c91 33 fields · synced 23 Oct 2026