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Helios® Automated Ifa System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref REF.IOS-1000Model 20110008
Identity
- Trade Name
- HELIOS® AUTOMATED IFA SYSTEM EUDAMEDFDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
- Device Name
- HELIOS® Automated IFA System EUDAMED
- Model / Reference
- REF.IOS-1000 EUDAMEDFDA UDI20110008 EUDAMED
Identifiers
- Catalog Number
- REF.IOS-1000 FDA UDI
- Primary DI / UDI-DI
- 04250289512541 EUDAMEDFDA UDI
- Basic UDI-DI
- 42502895HELIOSGR EUDAMED
- Direct Marketing DI
- 04250289512541 EUDAMED
- 510(k) Number
- K153117 FDA UDI
- FDA Product Code
- PIV FDA UDI
- EMDN Code
- W02069099 VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.4750 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Helios® Automated Ifa System by Aesku.Diagnostics GmbH & Co. KG — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (2)
- FDA UDI 57490d14-54b3-4938-839a-cc80632096f9 35 fields · synced Oct 7, 2026
- EUDAMED c8206b47-e788-4694-a106-5006b0122955 61 fields · synced Oct 6, 2026