Identity
- Trade Name
- EXR 120 EUDAMED
- Device Name
- Fluorescence Immunochromatography Analyzer EUDAMED
- Model / Reference
- 02-11-03-0005-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967200208 EUDAMED
- Basic UDI-DI
- 69732628600036ZT EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Exr 120 by Zybio Inc. — Class A — 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 | 69732628600036ZT | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 91584ccf-bf22-4289-bee4-c1a99ffe3e27 61 fields · synced Jul 14, 2026