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Output Module, Model: iTLA Max Out
EUDAMEDClass A (EU MDR)
Ref LX0255Model iTLA Max
Identity
- Trade Name
- Output Module, Model: iTLA Max Out EUDAMED
- Device Name
- Intelligent Total Laboratory Automation EUDAMED
- Model / Reference
- iTLA Max EUDAMEDLX0255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925912734901 EUDAMED
- Basic UDI-DI
- 692591270286HX EUDAMED
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Output Module, Model: iTLA Max Out by Shenzhen Yhlo Biotech Co., Ltd. — Class A — 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 | 692591270286HX | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Yhlo Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001137
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e855e9e6-e99a-463a-a90e-966edba424ef 61 fields · synced Sep 17, 2026