Identity
- Trade Name
- STROMATOLYSER-4DL EUDAMEDFDA UDI
- Generic Name
- Blood cell lysis reagent IVD FDA UDI
- Device Name
- STROMATOLYSER -4DL EUDAMEDThe STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* and WBC count* with Sysmex automated hematology analyzers (*on XS series only). FDA UDI
- Model / Reference
- 054-3321-2 EUDAMED984-176-15 EUDAMED98417615 FDA UDI
- Description
- The STROMATOLYSER-4DL is a reagent that lyses RBC for determination of 4-part differential count, or 5-part differential count* and WBC count* with Sysmex automated hematology analyzers (*on XS series only). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14987562509079 EUDAMED04987562201402 EUDAMEDFDA UDI
- Basic UDI-DI
- 4987562STROMATOLYSER4DLCC EUDAMED
- FDA Product Code
- GGK FDA UDI
- EMDN Code
- W0103010103 COMPLETE CELL COUNT EUDAMED
- GMDN Term
- Blood cell lysis reagent IVD 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
No
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
No
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
Stromatolyser-4dl 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 | 4987562STROMATOLYSER4DLCC | 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 (3)
- EUDAMED da78d985-cc49-45f0-9661-3f040945c155 61 fields · synced Jul 16, 2026
- EUDAMED 3a7efa3b-bc71-470d-bf60-09d764cb3735 61 fields · synced May 18, 2026
- FDA UDI df268db3-a430-42ab-889b-d821cca204b4 36 fields · synced May 30, 2026