Identity
- Trade Name
- C1qScreen™ EUDAMED
- Device Name
- C1qScreen™ C1q EUDAMED
- Model / Reference
- C1Q EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00812117016658 EUDAMED
- Basic UDI-DI
- 081211701C1Q5J EUDAMED
- Direct Marketing DI
- 00812117016658 EUDAMED
- EMDN Code
- W01030402 HLA ANTIBODY SCREENING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
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
C1qScreen™ by One Lambda, Inc. — Class C — 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 | 081211701C1Q5J | Class C | Active |
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Manufacturer
- Manufacturer
- One Lambda, Inc.
- EUDAMED SRN
- US-MF-000024901
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ba21717b-0e95-42ce-8a0a-7883e5443e95 61 fields · synced Jun 14, 2026