Identity
- Trade Name
- SendNTest® Urine EUDAMED
- Device Name
- SendNTest® Urine EUDAMED
- Model / Reference
- KST99990GS02.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598011823 EUDAMED
- Basic UDI-DI
- 4050598DVUrineSetVZ EUDAMED
- EMDN Code
- W05010299 URINE COLLECTION DEVICES - OTHER 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
SendNTest® Urine by Immundiagnostik AG — 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 | 4050598DVUrineSetVZ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED ae16fde0-f086-425c-b403-d9f9d6f37c2a 61 fields · synced Aug 2, 2026