← Back to catalogue
ABX Pentra XL80
EUDAMEDFDA UDIClass B (EU MDR)
Ref 1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851Model ABX Pentra XL80
Identity
- Trade Name
- ABX Pentra XL80 EUDAMEDABX PENTRA XL 80 FDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- ABX Pentra XL80 EUDAMEDABX PENTRA XL 80 (110V) FDA UDI
- Model / Reference
- ABX Pentra XL80 EUDAMED1280110025, 1280110027, 1280110029,1280110031,1280110033, 1280110035, 1280110036, 1280110038, 1300039850, 1300039851 EUDAMED1280110023, 1280110025 FDA UDI
- Description
- ABX PENTRA XL 80 (110V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006399 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_xl80LB EUDAMED
- 510(k) Number
- K024002 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
- GMDN Term
- Haematological cell analyser IVD FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
ABX Pentra XL80 by Horiba Abx Sas — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 361023pentra_xl80LB | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (3)
- EUDAMED 5e73193c-4758-4ec1-b9b6-446bf67ee1d1 61 fields · synced Jul 22, 2026
- FDA UDI f3296eaa-5944-4b9c-9b67-365793c0c964 34 fields · synced May 30, 2026
- EUDAMED 5e73193c-4758-4ec1-b9b6-446bf67ee1d1-1 61 fields · synced Jul 22, 2026