← Back to catalogue

Inorganic Phosphorus (P) Kit (Direct UV Method)

EUDAMED

Class IVD General (EU MDR)

Ref 01.09.0C.04.EC.01

Identity

Device Name: Inorganic Phosphorus (P) Kit (Direct UV Method) EUDAMED
Model / Reference: 01.09.0C.04.EC.01 EUDAMED

Identifiers

Primary DI / UDI-DI: 06941967223771 EUDAMED
Basic UDI-DI: B-06941967223771 EUDAMED
EMDN Code: W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Inorganic phosphate (PO43-) IVD, reagent

Inorganic Phosphorus (P) Kit (Direct UV Method) by Zybio Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Inorganic phosphate (PO43-) IVD, reagent.

BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Phosphorus UV, 2 x 100 mL — Chronolab Systems, S.L. · IVD General
Liquick Cor-PHOSPHORUS 30 — PZ CORMAY Spółka Akcyjna · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Pointe Scientific, Inc. Phosphorus — POINTE SCIENTIFIC, INC. · Class I
ACCENT-300 PHOSPHORUS — PZ CORMAY Spółka Akcyjna · IVD General
Alinity — Abbott · Class I
Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Zybio Inc.
EUDAMED SRN: CN-MF-000003349
Authorised Representative: Lotus NL B.V. NL-AR-000000121

Sources (1)

EUDAMED b14a2857-e4b9-43be-8ce1-f1bda13f1d66 61 fields · synced Jul 29, 2026