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ABX Pentra Clean-Chem 99 CP
EUDAMEDFDA UDIClass A (EU MDR)
Ref A11A01789Model A11A01755
Identity
- Trade Name
- ABX Pentra Clean-Chem 99 CP EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- ABX Pentra Clean-Chem CP EUDAMED
- Model / Reference
- A11A01755 EUDAMEDA11A01789 EUDAMED1220001789 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03610230005552 EUDAMEDFDA UDI
- Basic UDI-DI
- 361023pentra_clean_chemHQ EUDAMED
- Direct Marketing DI
- 03610230005552 EUDAMED
- 510(k) Number
- K052007 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2160 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 Clean-Chem 99 CP by Horiba Abx Sas — Class A — 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_clean_chemHQ | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
- EUDAMED SRN
- FR-MF-000000320
Sources (2)
- EUDAMED e4d12616-80f6-48ff-9c06-c3346e3c08a5 61 fields · synced May 30, 2026
- FDA UDI ebc849f6-1844-41c3-9cf6-cab8280cf2cc 33 fields · synced May 30, 2026