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ABX Pentra Calcium AS CP
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref A11A01954
Identity
- Trade Name
- ABX Pentra Calcium AS CP EUDAMEDFDA UDI
- Generic Name
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
- Device Name
- ABX Pentra Calcium AS CP EUDAMED
- Model / Reference
- A11A01954 EUDAMED1220001954 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005750 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_calcium_asM6 EUDAMED
- 510(k) Number
- K123171 FDA UDI
- FDA Product Code
- CJY FDA UDI
- EMDN Code
- W01010303 CALCIUM EUDAMED
- GMDN Term
- Calcium (Ca2+) IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1145 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
ABX Pentra Calcium AS CP by Horiba Abx Sas — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123171 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 361023pentra_calcium_asM6 | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (3)
- EUDAMED 6e37be2a-5186-4cdd-ac11-34dba11b7897 61 fields · synced Jul 11, 2026
- FDA UDI 5a44e00f-683b-44ba-89c4-a4c84942bf0f 33 fields · synced May 30, 2026
- FDA 510(k) K123171 1 fields · synced Jun 9, 2026