Identity
- Trade Name
- dsDNA-Ab RIA EUDAMED
- Device Name
- dsDNA-Ab RIA EUDAMED
- Model / Reference
- KIPIB19011 EUDAMEDRE19011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049325011373 EUDAMED04049325030657 EUDAMED
- Basic UDI-DI
- 4049325IVR06020003BR7 EUDAMED
- Direct Marketing DI
- 04049325011373 EUDAMED04049325030657 EUDAMED
- EMDN Code
- W0102100105 DS DNA - ANTIBODIES EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
dsDNA-Ab RIA by Ibl International Gmbh — Class B — 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 | 4049325IVR06020003BR7 | Class B | Active |
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Manufacturer
- Manufacturer
- IBL International GmbH
- EUDAMED SRN
- DE-MF-000015709
Sources (2)
- EUDAMED a9e748e8-7faa-4070-a263-93cd1cad16bf 61 fields · synced Jul 12, 2026
- EUDAMED 18d32694-e2f9-4fc9-999f-f933b0d6d4cd 61 fields · synced May 18, 2026