← Back to catalogue
Rubella IgG CLIA Microparticles
EUDAMEDClass C (EU MDR)
Ref CMK0801Model Autolumo analyzerRef CMK0803
Identity
- Trade Name
- Rubella IgG CLIA Microparticles EUDAMED
- Model / Reference
- Autolumo analyzer EUDAMEDCMK0801 EUDAMEDCMK0803 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150907082 EUDAMED06942359551892 EUDAMED
- Basic UDI-DI
- 697015090000106GZ EUDAMED
- EMDN Code
- W0105040102 RUBELLA VIRUS IGG EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
New Device
No
EUDAMED
Rubella IgG CLIA Microparticles by Autobio Diagnostics Co., Ltd. — 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 | 697015090000106GZ | Class C | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED a998da78-fb9b-4ed4-aa93-8400648a7f5f 61 fields · synced Jul 31, 2026
- EUDAMED ada57547-732b-4cf4-906a-7192658fb1b2 61 fields · synced May 19, 2026