Identity
- Trade Name
- Synergy H1 EUDAMEDH1M2-SI FDA UDI
- Generic Name
- Microplate reader IVD, automated/semi-automated FDA UDI
- Device Name
- Synergy H1 EUDAMEDMulti-Mode Microplate Reader FDA UDI
- Model / Reference
- H1F-SI EUDAMEDH1M2-SI EUDAMEDFDA UDI
- Description
- Multi-Mode Microplate Reader FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700574035259 EUDAMEDFDA UDI
- Basic UDI-DI
- 5700570000000000A0303016F EUDAMED
- FDA Product Code
- JJQ FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Microplate reader IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2300 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Synergy H1 by Agilent Technologies, Inc. — 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 | 5700570000000000A0303016F | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies, Inc.
- EUDAMED SRN
- US-MF-000009385
- Authorised Representative
- Agilent Technologies Denmark ApS DK-AR-000001443
Sources (2)
- EUDAMED 3c030282-6398-46a9-89cf-ca15fa5c98fc 61 fields · synced Jun 18, 2026
- FDA UDI 46b972cd-f507-4ff0-9412-501da2c67413 35 fields · synced May 29, 2026