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Microvolume UV/Vis (Nano)/Nucleic Acid Analyzer
EUDAMEDClass A (EU MDR)
Ref SP-MUV2000Ref SP-MUV2000F
Identity
- Trade Name
- Microvolume UV/Vis (Nano)/Nucleic Acid Analyzer EUDAMED
- Device Name
- Spectrophotometer EUDAMED
- Model / Reference
- SP-MUV2000 EUDAMEDSP-MUV2000F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975488440430 EUDAMED06975488440447 EUDAMED
- Basic UDI-DI
- 697548844SP22TY EUDAMED
- Direct Marketing DI
- 06975488440430 EUDAMED06975488440447 EUDAMED
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Microvolume UV/Vis (Nano)/Nucleic Acid Analyzer by Infitek 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 | 697548844SP22TY | Class A | Active |
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Manufacturer
- Manufacturer
- Infitek Co., Ltd.
- EUDAMED SRN
- CN-MF-000040107
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED b547c238-5ef0-4ea5-bce6-370be1e721e7 61 fields · synced Oct 6, 2026
- EUDAMED c92c9f5f-d02b-4a10-bc92-17631384cc6e 61 fields · synced May 17, 2026