Sample Preservation Solution

EUDAMED

Class A (EU MDR)

Ref 100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); etc.Model 100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); 12 tubes/box (3 mL/tube); 12 tubes/box (6 mL/tube)

by CapitalBio Technology (Chengdu) Co., Ltd.

Identity

Device Name: Sample Preservation Solution EUDAMED
Model / Reference: 100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); 12 tubes/box (3 mL/tube); 12 tubes/box (6 mL/tube) EUDAMED
100 tubes/box (1 mL/tube); 48 tubes/box (3 mL/tube); 48 tubes/box (6 mL/tube); etc. EUDAMED

Identifiers

Primary DI / UDI-DI: 06972221450282 EUDAMED
Basic UDI-DI: 697222145028FL EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Sample Preservation Solution by CapitalBio Technology (Chengdu) Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697222145028FL	Class A	Active

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Manufacturer

Manufacturer: CapitalBio Technology (Chengdu) Co., Ltd.
EUDAMED SRN: CN-MF-000027694
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (2)

EUDAMED 8779cdc3-0f06-4229-98e4-6ddd9f9aacf6 61 fields · synced Jul 11, 2026
EUDAMED 8779cdc3-0f06-4229-98e4-6ddd9f9aacf6-1 61 fields · synced Jun 9, 2026