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Renal Function Test Strip (Dry Chemistry)
EUDAMEDClass IVD General (EU MDR)
Ref 3028201001Model RFS-101（25pcs)
Identity
- Device Name
- Renal Function Test Strip (Dry Chemistry) EUDAMED
- Model / Reference
- RFS-101（25pcs) EUDAMED3028201001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712012458M EUDAMED
- Basic UDI-DI
- B-69717712012458M EUDAMED
- EMDN Code
- W010106040201 MULTIPLE PARAMETERS POC CONTROLS 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
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
Renal Function Test Strip (Dry Chemistry) 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-69717712012458M | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 783f8702-38b1-4644-bf06-8c6d68359dc0 61 fields · synced Oct 6, 2026