Identity
- Device Name
- Salus Pro Sequencing Reagent Set EUDAMED
- Model / Reference
- 21-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225660008 EUDAMED
- Basic UDI-DI
- 697522566pro5X 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
Yes
EUDAMED
Salus Pro 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 | 697522566pro5X | 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 69bba6c6-2472-4a8d-84d8-72a00c949d6f 61 fields · synced Jun 20, 2026