Substrate Solution

by Shenzhen Cinnaray Life Technology Co., Ltd. 19 variants

Ref A039110mLModel Architect-1, Architect-2, Alinity-1, Alinity-2, IM10, IM 11, BKM, XCY1, XCY2, AT-A, AT-B, MR, YHL-2, YHL-3, QS-A, QS-B, WG-A, WG-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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number698002989DWYTQ Basic UDI-DI 06980029891275UDI-DI	Date31 Aug 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Withdrawn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: Substrate Solution
Model / Reference: Architect-1, Architect-2, Alinity-1, Alinity-2, IM10, IM 11, BKM, XCY1, XCY2, AT-A, AT-B, MR, YHL-2, YHL-3, QS-A, QS-B, WG-A, WG-B, A039110mL

Primary DI / UDI-DI: 06980029891275
Basic UDI-DI: 698002989DWYTQ
EMDN Code: W0103010199 Reagents for (automated) haematology analyzer - other

Device Class: Class A
EU market of registration: Germany

Manufacturer details

EUDAMED SRN: CN-MF-000057751
Authorised representative: HUMISS TRADING S. L. ES-AR-000040177

Other devices from Shenzhen Cinnaray Life Technology Co., Ltd.

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Class A
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Substrate Solution

Class A
Lyse

Class A
DiLuent

Class A

See all devices from Shenzhen Cinnaray Life Technology Co., Ltd. →

Properties

Reagent
Professional Testing

Other properties (9)

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