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Atellica CH Inorganic Phosphorus (IP)
EUDAMEDClass B (EU MDR)
Ref 11645763Model IVDR_67_TTN_DUB-C_B_REAG_IP_c
Identity
- Trade Name
- Atellica CH Inorganic Phosphorus (IP) EUDAMED
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_IP_c EUDAMED
- Model / Reference
- IVDR_67_TTN_DUB-C_B_REAG_IP_c EUDAMED11645763 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00630414654034 EUDAMED
- Basic UDI-DI
- 0405686901733VU EUDAMED
- EMDN Code
- W01010307 PHOSPHATE INORGANIC / PHOSPHORUS EUDAMED
Classification
- Device Class
- Class B 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
New Device
No
EUDAMED
Category: Inorganic phosphate (PO43-) IVD, reagent
Atellica CH Inorganic Phosphorus (IP) by Siemens Healthcare Diagnostics — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Inorganic phosphate (PO43-) IVD, reagent.
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- 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0405686901733VU | Class B | Active |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- EUDAMED SRN
- US-MF-000016560
- Authorised Representative
- Siemens Healthcare Diagnostics Manufacturing Limited IE-AR-000006763
Sources (1)
- EUDAMED 77ea1b93-bde3-4fdb-833b-46c65f0e9073 61 fields · synced Jun 20, 2026