Identity
- Trade Name
- IDKhighX® stool preparation system – empty EUDAMED
- Device Name
- IDKhighX® stool preparation system EUDAMED
- Model / Reference
- K 6997X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04050598011830 EUDAMED
- Basic UDI-DI
- 4050598IAhighXE2 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
IDKhighX® stool preparation system – empty 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 | 4050598IAhighXE2 | Class A | Active |
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Manufacturer
- Manufacturer
- Immundiagnostik AG
- EUDAMED SRN
- DE-MF-000020905
Sources (1)
- EUDAMED e2be0275-2f0d-4982-b640-9058f1d64b21 61 fields · synced Jun 19, 2026