Identity
- Trade Name
- SaliCap Set EUDAMED
- Device Name
- SaliCap Set EUDAMED
- Model / Reference
- RE69985 EUDAMEDRE69981 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325033085 EUDAMED04049325033078 EUDAMED
- Basic UDI-DI
- 4049325IVR06080001ATD EUDAMED
- EMDN Code
- W05019002 SALIVA 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
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
SaliCap Set by Ibl International Gmbh — 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 | 4049325IVR06080001ATD | Class A | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED c8ace1e9-ce79-4981-a943-98e19c1205ca 61 fields · synced Sep 30, 2026
- EUDAMED 58bcb455-61e5-4e63-a73b-9eb5e5285ca4 61 fields · synced May 18, 2026