TDL-5G plus

by Zenith Lab (Jiangsu) Co., Ltd

Ref TDL-5G plus

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697637433TDL-5GplusU2 Basic UDI-DI 06976374330644UDI-DI	Date30 Jul 2024Registered	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Withdrawn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: TDL-5G plus
Model / Reference: TDL-5G plus

Primary DI / UDI-DI: 06976374330644
Basic UDI-DI: 697637433TDL-5GplusU2
EMDN Code: W02069003 Centrifuges

Device Class: Class A
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000026595
Authorised representative: Umedwings Netherlands B.V. NL-AR-000000444

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Properties

Surgical Instrument

Other properties (10)

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
New Device: No