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Salus EVO Sequencing Reagent Set
EUDAMEDClass A (EU MDR)
Ref 16-90-90-01-90Model PRH-PE100-1500M,PRH-PE150-1500M,PPH-PE100-2500M,PPH-PE150-2500M
Identity
- Device Name
- Salus EVO Sequencing Reagent Set EUDAMED
- Model / Reference
- PRH-PE100-1500M,PRH-PE150-1500M,PPH-PE100-2500M,PPH-PE150-2500M EUDAMED16-90-90-01-90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225660534 EUDAMED
- Basic UDI-DI
- 697522566evo4L EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Salus EVO Sequencing Reagent Set by Shenzhen Salus BioMed Co.. Ltd — 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 | 697522566evo4L | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Salus BioMed Co.. Ltd
- EUDAMED SRN
- CN-MF-000036126
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (1)
- EUDAMED 927ce2a4-cbfd-419a-9264-8dfc863c02c2 61 fields · synced Jun 18, 2026