Identity
- Trade Name
- EVIDENCE+ EUDAMEDEvidence MultiSTAT SHBG EUDAMEDEvidence MultiSTAT EUDAMEDFDA UDI
- Generic Name
- Multiplex analyser IVD, laboratory FDA UDI
- Device Name
- EVIDENCE+ EUDAMEDEvidence MultiSTAT SHBG EUDAMEDevidence MULTISTAT EUDAMEDThe Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories. FDA UDI
- Model / Reference
- EV4400 EUDAMEDEV4514 EUDAMEDEV4115 EUDAMEDFDA UDI
- Description
- The Evidence MultiSTAT is a benchtop, fully automated, immunoassay analyser that has been designed and developed to be operated in a wide range of laboratory settings within different industries. These include clinical, hospital, academic, research and development, veterinary and food laboratories. FDA UDI
Identifiers
- Catalog Number
- EV4115 FDA UDI
- Primary DI / UDI-DI
- 05055273216691 EUDAMED05055273219609 EUDAMED05055273214970 EUDAMEDFDA UDI
- Basic UDI-DI
- 50552732AEVIDEN019DW EUDAMED50552732BSHBGAK163CA EUDAMED50552732AEVMULT038SS EUDAMED
- Direct Marketing DI
- 05055273216691 EUDAMED05055273214970 EUDAMED
- 510(k) Number
- K220451 FDA UDI
- FDA Product Code
- JJE FDA UDI
- EMDN Code
- W0201020102,W0201020103,W0201020104 EUDAMEDW0102050109 SEX HORMONE BINDING GLOBULIN EUDAMEDW0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
- GMDN Term
- Multiplex analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass B 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Evidence+ 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 | 50552732AEVIDEN019DW | 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 (4)
- EUDAMED 5edced1a-a0ee-4455-bf65-629685f6e8de 61 fields · synced Jul 17, 2026
- EUDAMED ea84a1a5-064c-4d68-82a4-435da5af95b3 61 fields · synced May 18, 2026
- FDA UDI 0d00f40e-fe41-482d-8efa-2ad1d2111c8a 37 fields · synced May 30, 2026
- EUDAMED 5758f1fe-ba93-42fa-81b5-6beeb988e58a 61 fields · synced Jul 12, 2026