Identity
- Trade Name
- α-NAPHTHYL BUTYRATE ESTERASE, KIT, PART 1 EUDAMED
- Device Name
- α-NAPHTHYL BUTYRATE ESTERASE KIT EUDAMED
- Model / Reference
- 181B-1KT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061838755544 EUDAMED
- Basic UDI-DI
- 040618181JM 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
Α-Naphthyl Butyrate Esterase, Kit, Part 1 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 | 040618181JM | 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 2e7440dd-b580-4342-aca0-8bde3bec2e7f 61 fields · synced Jun 19, 2026