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Serum Amyloid A Protein Kit (Immunoassay)
EUDAMEDClass C (EU MDR)
Ref 01.09.30.01.01.05Model SR-I
by Zybio Inc.
Identity
- Device Name
- Serum Amyloid A Protein Kit (Immunoassay) EUDAMED
- Model / Reference
- SR-I EUDAMED01.09.30.01.01.05 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967224488 EUDAMED
- Basic UDI-DI
- 69732628600063ZW EUDAMED
- EMDN Code
- W01021199 RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany 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
Serum Amyloid A Protein Kit (Immunoassay) by Zybio 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 | 69732628600063ZW | Class C | Active |
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Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED d6ff6e3e-0864-4767-9365-fc6723c781f8 61 fields · synced Jun 19, 2026