← Back to catalogue
Dry Biochemical Analysis Meter
EUDAMEDClass IVD General (EU MDR)
Ref 3993400101Model DBM-101
Identity
- Device Name
- Dry Biochemical Analysis Meter EUDAMED
- Model / Reference
- DBM-101 EUDAMED3993400101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69717712090129L EUDAMED
- Basic UDI-DI
- B-69717712090129L EUDAMED
- EMDN Code
- W02020680 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
Dry Biochemical 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-69717712090129L | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Lysun Biotechnology Co., Ltd
- EUDAMED SRN
- CN-MF-000010254
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 69af44e4-594e-48ad-a1aa-acb1427bdefe 61 fields · synced Oct 6, 2026