← Back to catalogue
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Me…
EUDAMEDClass IVD General (EU MDR)
Ref 1AA15B11
Identity
- Trade Name
- Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) EUDAMED
- Device Name
- Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Method) EUDAMED
- Model / Reference
- 1AA15B11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950996004442 EUDAMED
- Basic UDI-DI
- B-06950996004442 EUDAMED
- EMDN Code
- W01021499 MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Analysis Kit for Fifteen Autoantibodies Spectrum (Flowcytometry Fluorescence Me… by Zhejiang Orient Gene Biotech Co., Ltd — Class IVD General — IVDD — listed…
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-06950996004442 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- EUDAMED SRN
- CN-MF-000017965
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 4729cc4f-ad56-469f-90ad-9f9f6cf1a6b9 61 fields · synced Jun 19, 2026