Identity
- Trade Name
- SULFOLYSER FDA UDI
- Generic Name
- Total haemoglobin (totHb) IVD, reagent FDA UDI
- Device Name
- SULFOLYSER EUDAMEDReagent for the automated determination of hemoglobin concentration of blood FDA UDI
- Model / Reference
- SLS-220A EUDAMEDFDA UDI
- Description
- Reagent for the automated determination of hemoglobin concentration of blood FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00664369200169 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562SULFOLYSERBV EUDAMED
- FDA Product Code
- GGK FDA UDI
- EMDN Code
- W0103010105 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS) EUDAMED
- GMDN Term
- Total haemoglobin (totHb) IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.8540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Liter FDA UDI
Sulfolyser by Sysmex Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 4987562SULFOLYSERBV | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sysmex Corporation
- EUDAMED SRN
- JP-MF-000014037
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (2)
- EUDAMED 8b85f0fa-90b2-4cb6-8173-a6a59ab3a4b8 61 fields · synced Jul 15, 2026
- FDA UDI 072cd40c-1ab7-4dd6-96c3-71e9faa4d12a 36 fields · synced May 30, 2026