Identity
- Trade Name
- FlexLab EUDAMEDFDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- Inpeco Total Laboratory Automation EUDAMEDThe FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation. FDA UDI
- Model / Reference
- TLA EUDAMEDFLX EUDAMEDFDA UDI
- Description
- The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates multiple Analytical instruments into a unified workstation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640172340004 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017234TLAKW EUDAMED
- Direct Marketing DI
- 07640172340004 EUDAMED
- 510(k) Number
- K121012 FDA UDI
- FDA Product Code
- CEM FDA UDI
- EMDN Code
- W02060101 AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS EUDAMED
- GMDN Term
- Specimen processing instrument IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1600 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
FlexLab by Inpeco SA — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 764017234TLAKW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Inpeco SA
- EUDAMED SRN
- CH-MF-000017833
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (2)
- EUDAMED 22549c9f-92ed-4370-9824-501b5fc52c6b 61 fields · synced Jul 12, 2026
- FDA UDI 0db7ccee-b2bd-498f-9d67-15e52943bb12 34 fields · synced May 30, 2026