Identity
- Trade Name
- HLA-B27 EUDAMED
- Device Name
- HLA-B27 EUDAMED
- Model / Reference
- RT-53 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08057680910329 EUDAMED
- Basic UDI-DI
- B-08057680910329 EUDAMED
- EMDN Code
- W0106010401 HLA-TYPING EUDAMED
Classification
- Device Class
- Class IVD Annex II List B 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
Hla-B27 by Clonit srl — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08057680910329 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clonit srl
- EUDAMED SRN
- IT-MF-000022196
Sources (1)
- EUDAMED 1aa029cc-9719-4f9d-a7e6-7a1bc0a1f6b0 61 fields · synced Jul 15, 2026