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Naphthol As -d Chloroacetate Esterase
EUDAMEDClass A (EU MDR)
Ref 91C-1KTModel 91Model 91A-1KT and 91C-1KT
Identity
- Trade Name
- NAPHTHOL AS -D CHLOROACETATE ESTERASE EUDAMEDLEUKOCYTE NAPHTHOL AS-D CHLOROACETATE (SPECIFIC ESTERASE) KIT EUDAMED
- Device Name
- NAPHTHOL AS -D CHLOROACETATE ESTERASE EUDAMEDLeukocyte α-Naphthyl Acetate (Non-Specific Esterase) and Leukocyte Naphthol AS-D Chloroacetate (Specific Esterase) Kit 91 EUDAMED
- Model / Reference
- 91 EUDAMED91C-1KT EUDAMED91A-1KT and 91C-1KT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061833264607 EUDAMED
- Basic UDI-DI
- 040618917Y 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
Naphthol As -d Chloroacetate Esterase 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 | 040618917Y | 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 (2)
- EUDAMED 728ae124-26d1-414f-9607-d60ba3d97c56 61 fields · synced Jun 18, 2026
- EUDAMED 3c65d4e4-5baa-43ca-a781-51d297d850a1 61 fields · synced Jun 18, 2026