Deep well plate

by Suzhou Acumen Biomedical Technology Co., LTD. 2 variants

Ref 220015-1, 220003, 220001-1, 220004-2, 220004-32

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

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number6978704662200FM Basic UDI-DI	Date2 Feb 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Deep well plate
Model / Reference: 220015-1, 220003, 220001-1, 220004-2, 220004-32

Primary DI / UDI-DI: 06978704661183, 06978704661145, 06978704661138, 06978704661121, 06978704661152, 06978704661176
Basic UDI-DI: 6978704662200FM
EMDN Code: W02050185 Nucleic acid testing instruments except micro-arrays - consumables

Device Class: Class A
EU market of registration: Portugal

Manufacturer details

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

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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