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Auto Hematology Analyzer

by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. 28 variants

Ref BC-31s, BC-7300[R] CRP, BC-7500[NR] CS, BC-21s, BC-7500[B] CS, BC-5180 CRP, BC-5390 CRP, Counter 31 AL, BC-700[R], BC-760[B] CS, BC-700[B] CS, BC-760[R], BC-7500[R] CRP, Unicorn 5, BC-6200, BC-20s, BC-6100Plus, BC-7500[N] CRP, BC-7500[N] CS, BC-700[B], BC-7500[R] CS, BC-20, BC-5380, BC-7600, BC-780[B] CS, BC-5140, BC-11, BC-7900, Dynacount 3D Plus, LT-360S, Counter XS 20, Counter 29, BC-720[R], Mispa CountZ, BC-31, BC-7300[NR] CRP, BC-10Model Please see UDI-DI for details, BC-7500[B] CRP、BC-7500[N] CRP、BC-7500[R] CRP、BC-7500[NR] CRP、BC-7300[B] CRP、BC-7300[N] CRP、BC-7300[R] CRP、BC-7300[NR] CRP、BC-7500[B] CS、BC-7500[N] CS、BC-7500[R] CS、BC-7500[NR] CS, BC-5390 CRP、BC-5180 CRP, BC-5390, Counter 31 AL, BC-700[B]、BC-700[R]、BC-720[R]、BC-760[B], BC-760[R], BC-780[R], BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ, BC-6000、BC-6000Plus、BC-6200、BC-6100、BC-6100Plus、Counter 60 AL, BC-5380、BC-5180, BC-7600, BC-7800, BC-7900

Active European Union and United States

CE IVDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160429↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number69449040AB3000013ZJ Basic UDI-DIDate22 Nov 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK160429 Date1 Sep 2016IssuedStatusActive

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 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
Please see UDI-DI for details, BC-31s, BC-7500[B] CRP、BC-7500[N] CRP、BC-7500[R] CRP、BC-7500[NR] CRP、BC-7300[B] CRP、BC-7300[N] CRP、BC-7300[R] CRP、BC-7300[NR] CRP、BC-7500[B] CS、BC-7500[N] CS、BC-7500[R] CS、BC-7500[NR] CS, BC-7300[R] CRP, BC-7500[NR] CS, BC-21s, BC-7500[B] CS, BC-5390 CRP、BC-5180 CRP, BC-5180 CRP, BC-5390 CRP, BC-5390, Counter 31 AL, BC-700[B]、BC-700[R]、BC-720[R]、BC-760[B], BC-760[R], BC-780[R], BC-700[R], BC-760[B] CS, BC-700[B] CS, BC-7500[R] CRP, BC-5000、BC-5120、BC-5130、BC-5140、BC-5150、Unicorn 5、Counter 29、Mispa CountZ, Unicorn 5, BC-6000、BC-6000Plus、BC-6200、BC-6100、BC-6100Plus、Counter 60 AL, BC-6200, BC-20s, BC-6100Plus, BC-7500[N] CRP, BC-7500[N] CS, BC-700[B], BC-7500[R] CS, BC-20, BC-5380、BC-5180, BC-5380, BC-7600, BC-7800, BC-7900, BC-780[B] CS, BC-5140, BC-11, Dynacount 3D Plus, LT-360S, Counter XS 20, Counter 29, BC-720[R], Mispa CountZ, BC-31, BC-7300[NR] CRP, BC-10
Primary DI / UDI-DI
06936415976903, 06936415988586, 06936415988609, 06936415976828, 06936415988593, 06936415976989, 06936415970871, 06903053040716, 06903053004428, 06903053014885, 06903053014854, 06903053014892, 06936415977122, 06903053040693, 06944904095738, 06944904051086, 06936415977047, 06936415977108, 06936415988616, 06903053004411, 06936415988623, 06936415976798, 06944904017655, 06903053079181, 06903053055024, 06936415976972, 06936415976774, 06903053079204, 06903053062299, 06903053106108, 06903053040648, 06903053040709, 06903053004435, 06903053046602, 06936415976859, 06936415988548, 06936415976750
Basic UDI-DI
69449040AB3000013ZJ, 69449040AB3000011ZE, 69449040AB3000016ZQ, 69449040AB3000015ZN, 69449040AB3000006ZM, 69449040AB3000007ZP, B-06903053014892, 69449040AB3000010ZC, 69449040AB3000019ZW, 69449040AB3000014ZL, 69449040AB3000023ZM
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
Device Class
Class B
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014156
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Professional Testing NoEUDAMEDYesEUDAMED
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No