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ToRCH IgM Control
EUDAMEDClass C (EU MDR)
Ref ZKB0402Model AutoLumo analyzerRef ZKB0202
Identity
- Trade Name
- ToRCH IgM Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKB0402 EUDAMEDZKB0202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150907495 EUDAMED06970150907471 EUDAMED
- Basic UDI-DI
- 697015090000359HY 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 IgM 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 | 697015090000359HY | 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 (2)
- EUDAMED b5660b55-fece-4359-b17b-e19ce8a5a9d5 61 fields · synced Jul 25, 2026
- EUDAMED 0577d772-1586-4dd7-9eb4-42a362dc5c78 61 fields · synced May 17, 2026