Identity
- Trade Name
- Alissa Interpret EUDAMEDFDA UDI
- Generic Name
- Human genomic analysis interpretive software IVD FDA UDI
- Device Name
- Alissa Interpret EUDAMEDFDA UDI
- Model / Reference
- K5849AA EUDAMEDFDA UDI
- Description
- Alissa Interpret FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700574035631 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0403P3011A040300MM EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W02079092 VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Human genomic analysis interpretive software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Alissa Interpret by Agilent Technologies Singapore (International) Pte Ltd — 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 | 570057R0403P3011A040300MM | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- EUDAMED SRN
- SG-MF-000014448
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (2)
- EUDAMED 678a4b6d-633f-417a-bf00-016000fb3d8b 61 fields · synced Oct 6, 2026
- FDA UDI 27919e46-30e0-413c-b2f8-5a70803fead8 35 fields · synced May 30, 2026