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Leucocyte Alkaline Phosphatase Kit
EUDAMEDClass A (EU MDR)
Ref FBS25-10CAPModel 85
Identity
- Device Name
- LEUCOCYTE ALKALINE PHOSPHATASE KIT EUDAMED
- Model / Reference
- 85 EUDAMEDFBS25-10CAP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061833622308 EUDAMED
- Basic UDI-DI
- 04061885LM3 EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS 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
Leucocyte Alkaline Phosphatase Kit by Sigma-Aldrich 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 | 04061885LM3 | Class A | Active |
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Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 7632a6fd-d6b4-4b20-913f-9f1ff65d158c 61 fields · synced Jun 18, 2026