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Autoimmune Maker Control I
EUDAMEDClass B (EU MDR)
Ref ZKE010101Model AutoLumo analyzer
Identity
- Trade Name
- Autoimmune Maker Control I EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKE010101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359520560 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 (1)
- EUDAMED bce01d1a-932e-4529-8808-536ba7ff3921 61 fields · synced Jun 19, 2026