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Temno® 10884450444334

by Merit Medical Systems, Inc.

Ref CT2215/BModel TEMNO®

Temno® 10884450444334 (CT2215/B) 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-00884450444337) and listed in FDA GUDID since 8 Dec 2021 (UDI-DI 00884450444337), 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-00884450444337 Basic UDI-DI 00884450444337UDI-DIDate2 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450444337 UDI-DI Date8 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450444337 registered 2 Nov 2026 Active
  • FDA GUDID UDI-DI 00884450444337 listed 8 Dec 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450444337
  2. Registered EUDAMED B-00884450444337

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  • Withdrawn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®
Generic name
Soft-tissue biopsy procedure kit, non-medicated
Device name
Merit Semi-Automatic Biopsy Devices
Model / Ref / Catalog
TEMNO®, CT2215/B, 10884450444334
Primary DI / UDI-DI
00884450444337 EUDAMED
10884450444334 GUDID
Basic UDI-DI
B-00884450444337
FDA product code
FCG
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 · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
TEMNO®
CT2215/B
GUDID
10884450444334
Primary DI / UDI-DIEUDAMED
00884450444337
GUDID
10884450444334
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00884450444337; FDA GUDID lists 10884450444334), so their flags are not compared. 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
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)