Erythrocyte Osmotic Fragility (EOF) Assay Kit (One-Tube Method)

EUDAMED

Class IVD General (EU MDR)

Ref Solution A: 60 mL, Solution B: 60 mL

by Shenzhen AmTech Bioengineering Ltd., Inc.

Identity

Device Name: Erythrocyte Osmotic Fragility (EOF) Assay Kit (One-Tube Method) EUDAMED
Model / Reference: Solution A: 60 mL, Solution B: 60 mL EUDAMED

Identifiers

Primary DI / UDI-DI: 06937287300322 EUDAMED
Basic UDI-DI: B-06937287300322 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class IVD General 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

Category: Nucleic acid extraction/isolation kit IVD

Erythrocyte Osmotic Fragility (EOF) Assay Kit (One-Tube Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED

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Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06937287300322	Class IVD General	Active

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Manufacturer

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
EUDAMED SRN: CN-MF-000043067
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (2)

EUDAMED d8453683-f3e0-4c49-82bf-18defcea82a4 61 fields · synced Jun 18, 2026
EUDAMED d8453683-f3e0-4c49-82bf-18defcea82a4-1 61 fields · synced Jun 9, 2026