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ToRCH IgG Control
EUDAMEDClass C (EU MDR)
Ref ZKA0102Model AutoLumo analyzerRef ZKA0402Ref ZKA0302
Identity
- Trade Name
- ToRCH IgG Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKA0102 EUDAMEDZKA0402 EUDAMEDZKA0302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150907303 EUDAMED06970150907334 EUDAMED06970150907327 EUDAMED
- Basic UDI-DI
- 697015090000358HW EUDAMED
- EMDN Code
- W0105080807 MULTICONSTITUENT CONTROLS - INF.IMM. EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Italy 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
ToRCH IgG Control 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 | 697015090000358HW | Class C | Active |
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Manufacturer
- Manufacturer
- Autobio Diagnostics Co., Ltd.
- EUDAMED SRN
- CN-MF-000003348
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (3)
- EUDAMED 4d133e8e-4dbc-45f1-a7ca-e8a48881a3f6 61 fields · synced Jul 28, 2026
- EUDAMED 254642c8-c7bb-4c51-a3a4-f8a392eb1c66 61 fields · synced May 17, 2026
- EUDAMED eb3e6a4e-bef1-46ab-a689-04a61d3494e8 61 fields · synced May 19, 2026