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BPro BT ABPM System

by Healthstats International Pte Ltd

Ref T6222Model T6200 Series

Withdrawn Withdrawn in European Union.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0888501441T6222WF Basic UDI-DI 08885014410098UDI-DIDate19 Aug 2022RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number08885014410098 UDI-DI Date14 Aug 2018ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Withdrawn
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
BPro BT ABPM System EUDAMED
BPro BT Ambulatory Blood Pressure Monitoring System GUDID
Generic Name
Blood pressure ambulatory recorder
Model / Reference
T6200 Series, T6222
Primary DI / UDI-DI
08885014410098
Basic UDI-DI
0888501441T6222WF
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN Term
Blood pressure ambulatory recorder
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1130
EU market of registration
Ireland
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
SG-MF-000025200
Authorised representative
MDSS GmbH DE-AR-000005430

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See all devices from Healthstats International Pte Ltd →

Properties

  • Measuring Function
  • Serial Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No