Identity
- Trade Name
- C1 SOLUTION (C1 SOLN) EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- C1 SOLUTION (C1 SOLN) EUDAMEDThis product is a weak bleach solution. FDA UDI
- Model / Reference
- RX2911 EUDAMEDRX8143 EUDAMEDFDA UDI
- Description
- This product is a weak bleach solution. FDA UDI
Identifiers
- Catalog Number
- RX8143 FDA UDI
- Primary DI / UDI-DI
- 05055273218817 EUDAMED05055273214994 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732AC1SOLN00937 EUDAMED
- FDA Product Code
- JJE 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
- 862.2160 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
C1 Solution (c1 Soln) by Randox Laboratories Limited — 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 | 50552732AC1SOLN00937 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories Limited
- EUDAMED SRN
- XI-MF-000028410
Sources (3)
- EUDAMED bd463314-3279-4991-b153-475e98ae0ec8 61 fields · synced Jul 25, 2026
- EUDAMED 475cef4d-7faf-4a48-9a66-57dd7038f919 61 fields · synced May 19, 2026
- FDA UDI ecb13e58-0e0e-46f0-934f-8cbed0b16191 36 fields · synced May 30, 2026