Identity
- Trade Name
- STROMATOLYSER-4DS EUDAMED
- Device Name
- STROMATOLYSER-4DS EUDAMED
- Model / Reference
- 054-3331-0 EUDAMED984-1721-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987562509086 EUDAMED14987562509093 EUDAMED
- Basic UDI-DI
- 4987562STROMATOLYSER4DSCS EUDAMED
- EMDN Code
- W0103010103 COMPLETE CELL COUNT 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
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Stromatolyser-4ds by Sysmex Corporation — 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 | 4987562STROMATOLYSER4DSCS | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 0253a1d5-488b-4780-a613-e9d0f1968669 61 fields · synced Jul 27, 2026
- EUDAMED 62a76c74-0871-4c51-9a5f-ff63bf51f421 61 fields · synced May 19, 2026