Identity
- Trade Name
- ISE Reference EUDAMED
- Device Name
- ISE Reference EUDAMED
- Model / Reference
- 981998 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153000850 EUDAMED
- Basic UDI-DI
- 6438153BU00139BZ EUDAMED
- Direct Marketing DI
- 16438153000850 EUDAMED
- EMDN Code
- W0101070301 REFERENCE ELECTRODES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Finland 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 Reference by Thermo Fisher Scientific Oy — 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 | 6438153BU00139BZ | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (1)
- EUDAMED 38019db5-9863-4938-86a9-ece9f124845f 61 fields · synced Oct 6, 2026