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Pentra XLR
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref 1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853Model Pentra XLR510(k) K151133
Identity
- Trade Name
- Pentra XLR EUDAMEDFDA UDI
- Generic Name
- Haematological cell analyser IVD FDA UDI
- Device Name
- Pentra XLR EUDAMEDPENTRA XLR (110V), PENTRA XLR (220V) FDA UDI
- Model / Reference
- Pentra XLR EUDAMED1280110003, 1280110005, 1280110007, 1280110009, 1280110011, 1280110013,1280110015, 1280110016, 1300039852, 1300039853 EUDAMED1280110003, 1280110005, 1280110007, 1280110009 FDA UDI
- Description
- PENTRA XLR (110V), PENTRA XLR (220V) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230006405 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_xlrEA EUDAMED
- 510(k) Number
- K151133 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
Pentra XLR 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 | K151133 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 361023pentra_xlrEA | Class B | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (4)
- EUDAMED 186ff7b5-0447-4ae3-a0ef-91f5707d6d72 85 fields · synced Jun 18, 2026
- FDA UDI 9db1bb3c-fdaf-46a4-8bb7-ec8987c247d6 34 fields · synced May 30, 2026
- EUDAMED 186ff7b5-0447-4ae3-a0ef-91f5707d6d72-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K151133 1 fields · synced May 18, 2026