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Multi-function analyzer - blood glucose
EUDAMEDClass IVD General (EU MDR)
Ref 3993500101Model GULP-101
Identity
- Device Name
- Multi-function analyzer (blood glucose, uric acid, blood lipid, blood pressure) EUDAMED
- Model / Reference
- GULP-101 EUDAMED3993500101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712001948N EUDAMED
- Basic UDI-DI
- B-69717712001948N EUDAMED
- EMDN Code
- W02020680 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- Models / Variants
- blood glucose EUDAMEDuric acid EUDAMEDblood lipid EUDAMEDblood pressure EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Romania 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
Multi-function analyzer - blood glucose by Hangzhou Lysun Biotechnology Co., Ltd — Class IVD General — IVDD — listed in EUDAMED — 4 models
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-69717712001948N | Class IVD General | Unknown |
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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 c53e6766-d43b-4add-bb82-1614890a735e 61 fields · synced Jun 18, 2026