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SPOTCHEM II Inorganic Phosphorus
EUDAMEDClass IVD General (EU MDR)
Ref 77179Ref 77414
Identity
- Trade Name
- SPOTCHEM II Inorganic Phosphorus EUDAMED
- Device Name
- SPOTCHEM II Inorganic Phosphorus EUDAMED
- Model / Reference
- 77179 EUDAMED77414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-77179JQ EUDAMEDD-77414JB EUDAMED
- Basic UDI-DI
- B-77179JQ EUDAMEDB-77414JB EUDAMED
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Finland EUDAMEDItaly 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
SPOTCHEM II Inorganic Phosphorus by ARKRAY Factory, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Inorganic phosphate (PO43-) IVD, reagent.
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- Fosforo UV — GIESSE DIAGNOSTICS SRL · IVD General
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-77179JQ | Class IVD General | Active |
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Manufacturer
- Manufacturer
- ARKRAY Factory, Inc.
- EUDAMED SRN
- JP-MF-000003008
- Authorised Representative
- ARKRAY Europe, B.V. NL-AR-000002056
Sources (2)
- EUDAMED 666d26f1-58d0-4b28-969f-936a4c3800bc 61 fields · synced Jul 27, 2026
- EUDAMED 23f00071-0404-46b3-a5cb-ed9040857265 61 fields · synced May 17, 2026