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Meritrans DTXPlus® 10884450371777

by Argon Critical Care Systems Singapore Pte. Ltd.

Ref 682012Model B

Meritrans DTXPlus® 10884450371777 (682012/B) is a device classified as Class IIa in the EU and Class II in the US made by Argon Critical Care Systems Singapore Pte. Ltd., registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI B-10884450371777) and listed in FDA GUDID since 18 Feb 2022 (UDI-DI 10884450371777), active as of 24 Oct 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884450371777 Basic UDI-DI 10884450371777UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884450371777 UDI-DI Date18 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10884450371777 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 10884450371777 listed 18 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884450371777
  2. Registered EUDAMED B-10884450371777

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  • Withdrawn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 DTXPlus®
Generic name
Invasive blood pressure transducer set
Model / Ref / Catalog
B EUDAMED
682012 EUDAMED
10884450371777 GUDID
682012/B GUDID
Primary DI / UDI-DI
10884450371777
Basic UDI-DI
B-10884450371777
FDA product code
DXN
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
870.1130
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
B
682012
GUDID
10884450371777
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 Argon Critical Care Systems Singapore Pte. Ltd.

See all devices from Argon Critical Care Systems Singapore Pte. Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Contains animal tissues or cells
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)