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PCR tube and plate

by Suzhou Acumen Biomedical Technology Co., LTD. 12 variants

Ref 260009-2, 260012-6, 260007-3, 260002-5, 260010-1, 230064-1, 260008-14, 260002-11, 260002-18, 260008-9, 260002-8, 260006-1, 260002-31, 260008-10, 260003-2, 260008-15

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 Number6978704662600G9 Basic UDI-DI Date2 Feb 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  • Withdrawn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
PCR tube and plate
Model / Reference
260009-2, 260012-6, 260007-3, 260002-5, 260010-1, 230064-1, 260008-14, 260002-11, 260002-18, 260008-9, 260002-8, 260006-1, 260002-31, 260008-10, 260003-2, 260008-15
Primary DI / UDI-DI
06978704661374, 06978704661237, 06978704661305, 06978704661190, 06978704661411, 06978704661442, 06978704661343, 06978704661398, 06978704661268, 06978704661312, 06978704661381, 06978704661404, 06978704661350, 06978704661244, 06978704661213, 06978704661329
Basic UDI-DI
6978704662600G9
EMDN Code
W050301029099 Samples analyses, plastic containers - other
Device Class
Class A
EU market of registration
Germany

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

Other properties (11)

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