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Duplica Real Time Mix & Match FACTOR V G1691A Kit
EUDAMEDClass C (EU MDR)
Ref EER038032
by Clonit srl
Identity
- Trade Name
- Duplica Real Time Mix & Match FACTOR V G1691A Kit EUDAMED
- Device Name
- Duplica Real Time Mix & Match FACTOR V G1691A Kit EUDAMED
- Model / Reference
- EER038032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680910015 EUDAMED
- Basic UDI-DI
- 805768091FVG1691_M01CH EUDAMED
- EMDN Code
- W0106010103 FACTOR V LEIDEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Duplica Real Time Mix & Match FACTOR V G1691A Kit by Clonit srl — 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 | 805768091FVG1691_M01CH | Class C | Active |
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Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED e08e38f6-6fd8-4d96-a09d-c86e5b38a7fd 61 fields · synced Sep 17, 2026