Identity
- Trade Name
- TDE 30 EUDAMED
- Device Name
- TDE 30 Reagent EUDAMED
- Model / Reference
- 1428 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720177655484 EUDAMED
- Basic UDI-DI
- 8720177600057785FL EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Tde 30 by Sakura Finetek Europe B.V. — 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 | 8720177600057785FL | Class A | Active |
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Manufacturer
- Manufacturer
- Sakura Finetek Europe B.V.
- EUDAMED SRN
- NL-MF-000023138
Sources (1)
- EUDAMED ee6d2f2b-d014-46cf-9706-362f0d06fe63 61 fields · synced Jul 8, 2026