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Semi-auto Chemistry Analyzer
EUDAMEDClass A (EU MDR)
Ref WP21BModel WP21A, WP21B, WP21ERef WP21ERef WP21A
Identity
- Device Name
- Semi-auto Chemistry Analyzer EUDAMED
- Model / Reference
- WP21A, WP21B, WP21E EUDAMEDWP21B EUDAMEDWP21E EUDAMEDWP21A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334802969 EUDAMED06950334802976 EUDAMED06950334809104 EUDAMED
- Basic UDI-DI
- 69503348WPA001P7 EUDAMED
- EMDN Code
- W0201010299 LIMITED PANEL CHEMISTRY ANALYSERS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- France 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
Semi-auto Chemistry Analyzer by Genrui Biotech Inc. — 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 | 69503348WPA001P7 | Class A | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (3)
- EUDAMED a14fd1ce-c4fb-466a-85c7-973c85664dd0 61 fields · synced Jul 17, 2026
- EUDAMED d771e62d-ecaa-46a9-9df4-d8ea540ee8ee 61 fields · synced May 17, 2026
- EUDAMED c171a32b-ada2-4d62-9c3e-170e8f395d32 61 fields · synced May 19, 2026