Identity
- Trade Name
- AMH Control EUDAMED
- Model / Reference
- AutoLumo analyzer EUDAMEDZK0101L302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942359507073 EUDAMED
- Basic UDI-DI
- 697015090000353HL EUDAMED
- EMDN Code
- W0102152002 HORMONE CONTROLS EUDAMED
Classification
- Device Class
- Class B 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
The AMH Control device is a medical device that utilizes Autobio Diagnostics Co., Ltd.'s innovative technology to accurately measure human tissues. This device is designed for near-patient testing and has undergone professional testing and sterilization procedures. The AMH Control device features a unique sensor array and advanced algorithms for precise data collection.
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 | 697015090000353HL | 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 c6962f04-0497-4c1d-837f-3a6a134e7a6c 61 fields · synced Jul 25, 2026