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Tumour Marker Control II
EUDAMEDClass C (EU MDR)
Ref ZKM0201Model AutoLumo analyzerRef ZKM0101
Identity
- Trade Name
- Tumour Marker Control II EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZKM0201 EUDAMEDZKM0101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970150909338 EUDAMED06970150909321 EUDAMED
- Basic UDI-DI
- 697015090000079HP EUDAMED
- EMDN Code
- W0102152005 TUMOUR MARKER CONTROLS EUDAMED
Classification
- Device Class
- Class C 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
Tumour Marker Control II 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 | 697015090000079HP | 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 a0b412f6-5d99-497a-aeca-87a340a99672 61 fields · synced Jul 8, 2026
- EUDAMED f4d45011-291f-422a-89a6-b169d70e8d7f 61 fields · synced May 19, 2026