Kuohai Technology

by Xiaogan Kuohai Medical Technology Co., Ltd. 12 variants

Ref KY-H(35ml)Model KY-H(35ml) KY-R(30ml) KY-E(25ml) KY-F(28ml) KY-A(20ml) KY-B(17ml) KY-C(15ml) KY-D(12ml) KY-G(10ml)

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	Number697718507KHCPSRE Basic UDI-DI 06977185070507UDI-DI	Date11 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Withdrawn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: Cell Preservation Solution
Model / Reference: KY-H(35ml) KY-R(30ml) KY-E(25ml) KY-F(28ml) KY-A(20ml) KY-B(17ml) KY-C(15ml) KY-D(12ml) KY-G(10ml), KY-H(35ml)

Primary DI / UDI-DI: 06977185070507
Basic UDI-DI: 697718507KHCPSRE
EMDN Code: W01030799 Histology / cytology reagents - other

Device Class: Class A
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000040038
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Reagent
Professional Testing

Other properties (9)