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Microplate Reader
EUDAMEDClass A (EU MDR)
Ref -Model AMR-100、AMR-100T、FlexA-200、FlexA-200HT、Feyond-A300、Feyond-A400、Feyond-A500
Identity
- Trade Name
- Microplate Reader EUDAMED
- Device Name
- Microplate Reader EUDAMED
- Model / Reference
- AMR-100、AMR-100T、FlexA-200、FlexA-200HT、Feyond-A300、Feyond-A400、Feyond-A500 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975141980907 EUDAMED06975141980891 EUDAMED06975141980914 EUDAMED06975141980860 EUDAMED
- Basic UDI-DI
- 697514198AS112EW EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMEDEUDAMED
Microplate Reader by Hangzhou Allsheng Instruments Co., Ltd — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697514198AS112EW | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Allsheng Instruments Co., Ltd
- EUDAMED SRN
- CN-MF-000020502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (4)
- EUDAMED 293f4527-1b6c-4cad-bc56-949dbc8772f1 61 fields · synced Jul 28, 2026
- EUDAMED 12d53fec-30a6-4cf7-aaf7-f16c82e04e18 61 fields · synced May 17, 2026
- EUDAMED f45bd28a-0e51-4dbc-b4cb-28298ec58d84 61 fields · synced May 17, 2026
- EUDAMED 5b73b833-5d16-40fa-8570-f34ffe957da5 61 fields · synced May 19, 2026