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Fluorescence Immunoassay Analyser
EUDAMEDClass A (EU MDR)
Ref FS100Model RTR-FS100
Identity
- Device Name
- Fluorescence Immunoassay Analyser EUDAMED
- Model / Reference
- RTR-FS100 EUDAMEDFS100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973597100061 EUDAMED
- Basic UDI-DI
- 697359710FS100HR EUDAMED
- Direct Marketing DI
- 06973597100061 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fluorescence Immunoassay Analyser by Xiamen United Medical 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 | 697359710FS100HR | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen United Medical Instruments Co., Ltd.
- EUDAMED SRN
- CN-MF-000028165
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED acfd1db2-c977-4991-bd93-c9326aba1567 61 fields · synced Jun 17, 2026