Identity
- Trade Name
- ISE High Serum Standard EUDAMED
- Device Name
- ISE High Serum Standard EUDAMED
- Model / Reference
- 66316 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590160036 EUDAMED
- Basic UDI-DI
- 15099590266316T9 EUDAMED
- EMDN Code
- W01010399 ELECTROLYTES - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Ireland 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
ISE High Serum Standard by Beckman Coulter Ireland Inc. — Class B — 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 | 15099590266316T9 | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED a44f78b8-5386-4a60-abb8-6bf4e460069c 61 fields · synced Jun 18, 2026