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Non Vacuum Blood Collection Tube

EUDAMED

Class A (EU MDR)

Ref No AdditiveModel No Additive, Clot Activator, Gel & Clot Activator, Sodium Citrate (1:4), Sodium Citrate (1:9), Sodium Heparin, Lithium Heparin, EDTA K2, EDTA K3, Sodium Fluoride

by Sinopharm Fortune International Trading Corp.

Identity

Device Name
Non Vacuum Blood Collection Tube EUDAMED
Model / Reference
No Additive, Clot Activator, Gel & Clot Activator, Sodium Citrate (1:4), Sodium Citrate (1:9), Sodium Heparin, Lithium Heparin, EDTA K2, EDTA K3, Sodium Fluoride EUDAMED
No Additive EUDAMED

Identifiers

Primary DI / UDI-DI
06976800671181 EUDAMED
Basic UDI-DI
697680067NVBCTU2 EUDAMED
EMDN Code
W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Austria EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Non Vacuum Blood Collection Tube by Sinopharm Fortune International Trading Corp. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000038309
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED a5459be7-40dc-4aff-8ca1-77cf67e954de 61 fields · synced Jul 12, 2026