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bKIT Immunofinder dqTACT MS
EUDAMEDClass IVD General (EU MDR)
Ref HK032X260Model bKIT Immunofinder dqTACT MSRef HK032X300Ref HK032X130
by Hyris Srl
Identity
- Trade Name
- bKIT Immunofinder dqTACT MS EUDAMED
- Device Name
- bKIT Immunofinder dqTACT MS EUDAMED
- Model / Reference
- bKIT Immunofinder dqTACT MS EUDAMEDHK032X260 EUDAMEDHK032X300 EUDAMEDHK032X130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80575074301088 EUDAMED80575074301156 EUDAMED80575074300920 EUDAMED
- Basic UDI-DI
- B-80575074301088 EUDAMEDB-80575074301156 EUDAMEDB-80575074300920 EUDAMED
- EMDN Code
- W01030699 LYMPHOKINES /IMMUNMODULATORS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General 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
bKIT Immunofinder dqTACT MS by Hyris Srl — Class IVD General — 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-80575074301088 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hyris Srl
- EUDAMED SRN
- IT-MF-000031635
Sources (3)
- EUDAMED 4a3492ba-293e-4c3f-ab18-3fd05b84d0af 61 fields · synced Jul 21, 2026
- EUDAMED 08b801c5-765b-473c-b312-ea51569599d2 61 fields · synced May 17, 2026
- EUDAMED 8b1355b9-dc16-4f87-aee3-d782ec74bed7 61 fields · synced May 18, 2026