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Autoimmune Maker Control I
EUDAMEDClass B (EU MDR)
Ref ZKE010201Model AutoLumo analyzerRef ZKE010301
Identity
- Trade Name
- Autoimmune Maker Control I EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKE010201 EUDAMEDZKE010301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359520614 EUDAMED06942359520669 EUDAMED
- Basic UDI-DI
- 697015090000127H9 EUDAMED
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class B 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
Autoimmune Maker Control I 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 | 697015090000127H9 | Class B | 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 6a8d4f3f-a547-4ec7-a0af-96aea3089a9d 61 fields · synced Jul 14, 2026
- EUDAMED 53717f40-7b43-4ccf-b7ab-39002896ede1 61 fields · synced May 18, 2026