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Unimed DP-MX

by Unimed Medical Supplies, Inc.

Ref DP-MX

Unimed DP-MX is a device classified as Class IIb in the EU and Class II in the US made by Unimed Medical Supplies, Inc., registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI B-06945664877367), cleared under FDA 510(k) K152472 on 31 Oct 2016 and listed in FDA GUDID since 8 Sep 2021 (UDI-DI 06945664877367), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K152472

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06945664877367 Basic UDI-DI 06945664877367UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06945664877367 UDI-DI Date8 Sep 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK152472 Date31 Oct 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06945664877367 registered 5 Nov 2026 Active
  • FDA 510(k) K152472 decided 31 Oct 2016 Active
  • FDA GUDID UDI-DI 06945664877367 listed 8 Sep 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K152472
  2. Listed FDA GUDID 06945664877367
  3. Registered EUDAMED B-06945664877367

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Disposable Blood Pressure Transduser EUDAMED
Unimed GUDID
Generic name
Invasive-pressure external transducer, single-use
Model / reference
DP-MX
Primary DI / UDI-DI
06945664877367
Basic UDI-DI
B-06945664877367
510(k) Number
FDA product code
DRS
EMDN code
Z1203020301 Invasive blood pressure monitoring instruments
GMDN term
Invasive-pressure external transducer, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.2850
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Supplied sterile UDI-DI 06945664877367: EUDAMED states Yes, FDA GUDID states No.

Device class is stated on each registry's own scale: Class IIb 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-pressure external transducer, single-use

Cleared under the same submission (K152472)

and 8 more cleared under K152472

Similar devices in this category

Other devices filed under INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from Unimed Medical Supplies, Inc.

See all devices from Unimed Medical Supplies, Inc. →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)