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Prealbumin (PA) Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.00.15.EC.01Ref 01.09.00.15.EC.02
by Zybio Inc.
Identity
- Device Name
- Prealbumin (PA) Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.00.15.EC.01 EUDAMED01.09.00.15.EC.02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967209058 EUDAMED06941967209065 EUDAMED
- Basic UDI-DI
- B-06941967209058 EUDAMEDB-06941967209065 EUDAMED
- EMDN Code
- W0102010305 PRE-ALBUMIN / TRANSTHYRETIN EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Prealbumin (PA) Kit (Immunoturbidimetric Method) by Zybio Inc. — 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-06941967209058 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 0d2e8976-0878-44b9-b12f-951c3bba7ef7 61 fields · synced Jul 25, 2026
- EUDAMED e69a7618-1410-4032-8188-954a29d698ce 61 fields · synced May 18, 2026