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Renal Function Analysis Meter
EUDAMEDClass IVD General (EU MDR)
Ref RFM-202Ref W02020680Model RFM-101
Identity
- Trade Name
- Renal Function Analysis Meter EUDAMED
- Device Name
- Renal Function Analysis Meter EUDAMED
- Model / Reference
- RFM-202 EUDAMEDRFM-101 EUDAMEDW02020680 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971771200521 EUDAMEDD-6971771209036A2 EUDAMED
- Basic UDI-DI
- B-06971771200521 EUDAMEDB-6971771209036A2 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMEDW02020680 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMEDEUDAMED
Surgical Instrument
Yes
EUDAMED
Renal Function Analysis Meter by Hangzhou Lysun Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06971771200521 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED b5cdbbab-8a65-4af8-a1c9-b820dc2990a5 61 fields · synced Oct 6, 2026
- EUDAMED 12b5516b-cf05-4ca6-8903-5285a460863c 61 fields · synced May 17, 2026