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Blood Pressure Monitor

by Bioland Technology Ltd. 4 variants

Ref A802, 3001, A603, A803, 3005, A704, 2006-2B, A800, 3002, A604, A801, A703

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

CE MDR CE MDD 510(k)

Valid until

Not listed

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

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, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number6939184610001AP Basic UDI-DI Date13 Jun 2024RegisteredStatusActive
European UnionCE/MDR EUDAMED Number6939184610001AP Basic UDI-DI Date13 Jun 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK202934 Date26 Jan 2021IssuedStatusActive
United StatesGUDID listing GUDID Number06939184610368 UDI-DI Date16 Nov 2020ListedStatusListed GUDID: 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  • Withdrawn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/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Blood Pressure Monitor EUDAMED
bioland GUDID
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
A802, 3001, A603, A803, 3005, A704, 2006-2B, A800, 3002, A604, A801, A703
Primary DI / UDI-DI
06939184610368, 06939184610856, 06939184610269, 06939184610375, 06939184630052, 06939184610344, 06939184610054, 06939184610078, 06939184610665, 06939184610276, 06939184610351, 06939184610337
Basic UDI-DI
6939184610001AP, B-06939184610856, B-06939184630052, B-06939184610054, B-06939184610665
Direct Marketing DI
06939184610368
06939184610269
06939184610375
06939184610344
06939184610078
06939184610276
06939184610351
06939184610337
06939184610054
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1130
EU market of registration
Malta
Northern Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000010625
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Bioland Technology Ltd.

See all devices from Bioland Technology Ltd. →

Properties

  • Measuring Function
  • Over-the-Counter
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No