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Inorganic Phosphorus (P)
EUDAMEDClass IVD General (EU MDR)
Ref ECH0107257Ref ECH0101257Ref ECH0105257Ref ECH0106257
Identity
- Device Name
- Inorganic Phosphorus (P) EUDAMED
- Model / Reference
- ECH0107257 EUDAMEDECH0101257 EUDAMEDECH0105257 EUDAMEDECH0106257 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ECH01072576L EUDAMEDD-ECH01012575A EUDAMEDD-ECH010525766 EUDAMEDD-ECH01062576D EUDAMED
- Basic UDI-DI
- B-ECH01072576L EUDAMEDB-ECH01012575A EUDAMEDB-ECH010525766 EUDAMEDB-ECH01062576D 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) by Maccura Biotechnology Co., Ltd. — 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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- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-ECH01072576L | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000014618
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (4)
- EUDAMED cc799fff-75dd-441e-adc6-27d4214dd856 61 fields · synced Jul 24, 2026
- EUDAMED f8773d30-1604-4417-9205-38fb46715421 61 fields · synced May 18, 2026
- EUDAMED 7aaea643-4808-4f15-8327-d023017b1b50 61 fields · synced May 18, 2026
- EUDAMED 0ba97384-98cf-4220-83f5-32fb6aa24f2e 61 fields · synced May 19, 2026