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I.s.e. Cleaning Solution (i.s.e. Soln Wash)
EUDAMEDFDA UDIClass A (EU MDR)
Ref RX4003
Identity
- Trade Name
- I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH) EUDAMEDSOLN WASH FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- I.S.E. CLEANING SOLUTION (I.S.E. SOLN WASH) EUDAMEDThis should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample cup but the cup must be covered between use to eliminate evaporation and ensure accuracy. FDA UDI
- Model / Reference
- RX4003 EUDAMEDFDA UDI
- Description
- This should be run once a day to prevent protein build up or at 8 hour intervals if the ISE module performs more than 50 samples per day. Cleaning solution may be aspirated from a sample cup but the cup must be covered between use to eliminate evaporation and ensure accuracy. FDA UDI
Identifiers
- Catalog Number
- RX4003 FDA UDI
- Primary DI / UDI-DI
- 05055273210361 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732AISESOL006MP EUDAMED
- FDA Product Code
- JJF FDA UDI
- EMDN Code
- W0201010185 CHEMISTRY ANALYSERS - CONSUMABLES EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2170 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
I.s.e. Cleaning Solution (i.s.e. Soln Wash) by Randox Laboratories Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50552732AISESOL006MP | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (2)
- EUDAMED 64a5beed-1d98-4124-a96a-d770dd8ba0a1 61 fields · synced Jun 19, 2026
- FDA UDI 8efa8de0-447c-4731-b719-7f8e4100f118 36 fields · synced May 30, 2026