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Meritrans® 00884450240458

by Merit Medical Systems, Inc.

Ref K11-00099BModel Initial Release

Meritrans® 00884450240458 (K11-00099B) 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 25 Oct 2026 (Basic UDI-DI B-00884450240458) and listed in FDA GUDID since 13 Sep 2018 (UDI-DI 00884450240458), 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-00884450240458 Basic UDI-DI 00884450240458UDI-DIDate25 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884450240458 UDI-DI Date13 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00884450240458 registered 25 Oct 2026 Active
  • FDA GUDID UDI-DI 00884450240458 listed 13 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00884450240458
  2. Registered EUDAMED B-00884450240458

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  • Withdrawn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
Meritrans®
Generic name
Invasive blood pressure transducer set
Model / Ref / Catalog
Initial Release, K11-00099B, 00884450240458
Primary DI / UDI-DI
00884450240458
Basic UDI-DI
B-00884450240458
FDA product code
OEZ
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive blood pressure transducer set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1200
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
Initial Release
K11-00099B
GUDID
00884450240458
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: Invasive blood pressure transducer set

Similar devices in this category

Other devices filed under INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

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
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)