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TEMNO Elite™ 00884450397954

by Merit Medical Systems, Inc.

Ref CX1415Model Coaxial Introducer

TEMNO Elite™ 00884450397954 (CX1415) is a device classified as Class IIa in the EU and Class II in the US made by Merit Medical Systems, Inc., registered in EUDAMED on 2 Nov 2026 (Basic UDI-DI B-00884450397954) and listed in FDA GUDID since 17 Aug 2023 (UDI-DI 00884450397954), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00884450397954 Basic UDI-DI 00884450397954UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450397954 UDI-DI Date17 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450397954 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00884450397954 listed 17 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450397954
  2. Registered EUDAMED B-00884450397954

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
TEMNO Elite™
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
Temno Elite Biopsy System
Model / Ref / Catalog
Coaxial Introducer, CX1415, 00884450397954
Primary DI / UDI-DI
00884450397954
Basic UDI-DI
B-00884450397954
FDA product code
KNW
EMDN code
A010299 Biopsy needles and kits - other
GMDN term
Soft-tissue biopsy procedure kit, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1075
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Coaxial Introducer
CX1415
GUDID
00884450397954
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Soft-tissue biopsy procedure kit, non-medicated

Similar devices in this category

Other devices filed under BIOPSY NEEDLES AND KITS - OTHER.

Other devices from Merit Medical Systems, Inc.

See all devices from Merit Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (17, all answered No)