Skip to content

Safedraw™ 10884450544157

by Argon Critical Care Systems Singapore Pte. Ltd.

Ref 689721Model B

Safedraw™ 10884450544157 (689721/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 19 Oct 2026 (Basic UDI-DI B-10884450544157) and listed in FDA GUDID since 27 Jan 2021 (UDI-DI 10884450544157), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10884450544157 Basic UDI-DI 10884450544157UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884450544157 UDI-DI Date27 Jan 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10884450544157 registered 19 Oct 2026 Active
  • FDA GUDID UDI-DI 10884450544157 listed 27 Jan 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10884450544157
  2. Registered EUDAMED B-10884450544157

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  • Withdrawn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
Safedraw™
Generic name
Invasive blood pressure transducer set
Model / Ref / Catalog
B EUDAMED
689721 EUDAMED
10884450544157 GUDID
689721/B GUDID
Primary DI / UDI-DI
10884450544157
Basic UDI-DI
B-10884450544157
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
689721
GUDID
10884450544157
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
  • Manufacturing date
Other properties (18, all answered No)