Identity
- Trade Name
- SureScan Dx Microarray Scanner EUDAMEDFDA UDI
- Generic Name
- Microarray analyser IVD FDA UDI
- Device Name
- SureScan Dx Microarray Scanner EUDAMEDFDA UDI
- Model / Reference
- G5761A EUDAMEDFDA UDI
- Description
- SureScan Dx Microarray Scanner FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571108703 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057R0802P3011A040200S3 EUDAMED
- Direct Marketing DI
- 05700571108703 EUDAMED
- FDA Product Code
- NSU FDA UDI
- EMDN Code
- W02050299 MICRO-ARRAY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microarray analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- 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
Yes
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SureScan Dx Microarray Scanner 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 | 570057R0802P3011A040200S3 | 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 cfc4ca0a-3dad-4c46-a985-422546a92f32 61 fields · synced Jun 18, 2026
- FDA UDI eb806f8f-e86a-42ca-8b9b-78f1c314aeca 35 fields · synced May 30, 2026