← Back to catalogue
Thyroid Speciality Control
EUDAMEDClass B (EU MDR)
Ref ZK0501L106Model AutoLumo analyzerRef ZK0501L206
Identity
- Trade Name
- Thyroid Speciality Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZK0501L106 EUDAMEDZK0501L206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359522656 EUDAMED06942359522663 EUDAMED
- Basic UDI-DI
- 697015090000130GW EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
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
Thyroid Speciality Control by Autobio Diagnostics Co., Ltd. — Class B — 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 | 697015090000130GW | Class B | 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 5e9ada92-b4f5-42d9-b315-7fd544f3f210 61 fields · synced Aug 2, 2026
- EUDAMED a6a2db17-f70c-4d7b-a8a5-787255e5f764 61 fields · synced May 18, 2026