Identity
- Trade Name
- SULFOLYSER EUDAMED
- Device Name
- SULFOLYSER EUDAMED
- Model / Reference
- 054-3351-4 EUDAMED904-1131-7 EUDAMED904-1141-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14987562509253 EUDAMED14987562509260 EUDAMED04987562510948 EUDAMED
- Basic UDI-DI
- 4987562SULFOLYSERBV EUDAMED
- EMDN Code
- W0103010504 HAEMOGLOBIN CONTROLS 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
Sulfolyser 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 | 4987562SULFOLYSERBV | Class A | Active |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (3)
- EUDAMED e25dd82f-3d7a-4f9c-80b7-253905297f1a 61 fields · synced Jul 20, 2026
- EUDAMED d1111fcb-8744-4dcf-84b8-b63cc973d98e 61 fields · synced May 18, 2026
- EUDAMED dd6c821f-3d32-4305-bda5-6b37f263b735 61 fields · synced May 19, 2026