Identity
- Trade Name
- Melatonin direct Saliva ELISA EUDAMEDMelatonin ELISA EUDAMED
- Device Name
- Melatonin direct Saliva ELISA EUDAMEDMelatonin ELISA EUDAMED
- Model / Reference
- RE54041 EUDAMEDRE54021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325030589 EUDAMED04049325001947 EUDAMED
- Basic UDI-DI
- 4049325IVR06080013BTS EUDAMEDB-04049325001947 EUDAMED
- Direct Marketing DI
- 04049325030589 EUDAMED
- EMDN Code
- W0102069003 MELATONINE EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMEDEUDAMED
Animal Tissues
Yes
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
Melatonin direct Saliva ELISA by Ibl International Gmbh — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 4049325IVR06080013BTS | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 4049325IVR06080013BTS | Class B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED cc3e9b04-86e9-4a10-a11a-3983c0670107 61 fields · synced Jul 12, 2026
- EUDAMED 13d2f97f-4cba-4570-a428-7f3689bc3507 61 fields · synced Jun 14, 2026