Identity
- Device Name
- Alternative matrix for mass spectrometry EUDAMED
- Model / Reference
- 3011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08588007926278 EUDAMED
- Basic UDI-DI
- 858800792630113F EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Slovakia 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
No
EUDAMED
New Device
No
EUDAMED
Alternative matrix for mass spectrometry by Diagnostics s.r.o. — 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 | 858800792630113F | Class A | Active |
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Manufacturer
- Manufacturer
- Diagnostics s.r.o.
- EUDAMED SRN
- SK-MF-000038255
Sources (1)
- EUDAMED 2dff93d6-5fe8-4a0b-84fd-a80b02a908c3 61 fields · synced Jun 20, 2026