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Genetic Sequencer
EUDAMEDClass A (EU MDR)
Ref 21-09Model Salus ProModel Salus EVO
Identity
- Trade Name
- Genetic Sequencer EUDAMEDGenetic Sequencer (Salus EVO) EUDAMED
- Device Name
- Genetic Sequencer EUDAMEDGenetic Sequencer (Salus EVO) EUDAMED
- Model / Reference
- Salus Pro EUDAMED21-09 EUDAMEDSalus EVO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225660626 EUDAMED06975225660602 EUDAMED
- Basic UDI-DI
- 697522566PRO0001VC EUDAMED697522566SalusEVOYL EUDAMED
- Direct Marketing DI
- 06975225660626 EUDAMED06975225660602 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMEDEUDAMED
Genetic Sequencer 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 | 697522566PRO0001VC | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Salus BioMed Co.. Ltd
- EUDAMED SRN
- CN-MF-000036126
- Authorised Representative
- Umedwings Netherlands B.V. NL-AR-000000444
Sources (2)
- EUDAMED c88ede0b-a61b-47b3-9637-36222976441f 61 fields · synced Jul 26, 2026
- EUDAMED 3e663052-5490-43e7-946c-848b4c6e79b1 61 fields · synced May 18, 2026