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Sample tip (including conductive)

by Suzhou Acumen Biomedical Technology Co., LTD. 52 variants

Ref 210003-5, 210045-2, 210007-21, 210055-61, 210039-12, 210012-13, 210035-31, 210011-18, 210050, 210006-2, 210035-9, 210006-16, 210012-14, 210055-49, 210003-6, 210054-26, 06978704660315, 210005-9, 210008-6, 210006-1, 210040-2, 210055-45, 210041-4, 210040-5, 210011-17, 210035-3, 210007-3, 210012-26, 210055-26, 210045, 210043, 210041-5, 210003-12, 210055-24, 210030-1, 210054-23, 210012-20, 210055-22, 210011-20, 210007-4, 210009-3, 210011-26, 210027, 210007-24, 210055-15, 210019-1, 210007-1, 210043-11, 210001-5, 210008-2, 210034-1Model ACAF050-H-TP-B

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6978704662100FG Basic UDI-DI Date30 Jan 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Sample tip (including conductive)
Model / Reference
ACAF050-H-TP-B, 210003-5, 210045-2, 210007-21, 210055-61, 210039-12, 210012-13, 210035-31, 210011-18, 210050, 210006-2, 210035-9, 210006-16, 210012-14, 210055-49, 210003-6, 210054-26, 06978704660315, 210005-9, 210008-6, 210006-1, 210040-2, 210055-45, 210041-4, 210040-5, 210011-17, 210035-3, 210007-3, 210012-26, 210055-26, 210045, 210043, 210041-5, 210003-12, 210055-24, 210030-1, 210054-23, 210012-20, 210055-22, 210011-20, 210007-4, 210009-3, 210011-26, 210027, 210007-24, 210055-15, 210019-1, 210007-1, 210043-11, 210001-5, 210008-2, 210034-1
Primary DI / UDI-DI
06978704660056, 06978704661077, 06978704660971, 06978704660865, 06978704660506, 06978704660247, 06978704660452, 06978704660209, 06978704660698, 06978704661060, 06978704660483, 06978704660100, 06978704660254, 06978704660858, 06978704660063, 06978704660742, 06978704660315, 06978704661084, 06978704660148, 06978704661046, 06978704660575, 06978704660841, 06978704660612, 06978704660605, 06978704660193, 06978704660445, 06978704660957, 06978704660278, 06978704660810, 06978704660889, 06978704660650, 06978704660629, 06978704660032, 06978704660803, 06978704660353, 06978704660735, 06978704660261, 06978704660797, 06978704660216, 06978704660964, 06978704660162, 06978704660223, 06978704660346, 06978704660117, 06978704660773, 06978704661114, 06978704661053, 06978704660902, 06978704660018, 06978704660124, 06978704660407
Basic UDI-DI
6978704662100FG
EMDN Code
W0503020199, W02069099
Device Class
Class A
EU market of registration
Spain
Germany
Portugal

Manufacturer details

EUDAMED SRN
CN-MF-000038603
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Suzhou Acumen Biomedical Technology Co., LTD.

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Properties

  • Professional Testing

Other properties (10)

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