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RS32 All In One Digital PCR System
EUDAMEDClass A (EU MDR)
Ref RS3204 , RS3205, RS3206, RS3207
Identity
- Device Name
- RS32 All In One Digital PCR System EUDAMED
- Model / Reference
- RS3204 , RS3205, RS3206, RS3207 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470131 EUDAMED
- Basic UDI-DI
- 697576047RS32S3 EUDAMED
- EMDN Code
- W02050180 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
RS32 All In One Digital PCR System by Suzhou Precigenome Ltd, Co; — 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 | 697576047RS32S3 | Class A | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 1e8ca204-5a75-4e81-a144-bf48e74fc416 61 fields · synced Aug 5, 2026
- EUDAMED 1e8ca204-5a75-4e81-a144-bf48e74fc416-1 61 fields · synced Jun 9, 2026