Identity
- Trade Name
- Decapper Flex, TCA EUDAMEDFDA UDI
- Generic Name
- Specimen processing instrument IVD FDA UDI
- Device Name
- Buffer, TCA EUDAMEDDecapper Flex, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices. FDA UDI
- Model / Reference
- 952039 EUDAMED1 FDA UDI
- Description
- Decapper Flex, TCA is a module of TCAutomation Laboratory Automation System. TCAutomation is a modular system used to automate the handling of sample tubes in the pre- and post- analytical steps of in vitro examination procedures, typically in combination with in vitro diagnostic medical devices. FDA UDI
Identifiers
- Catalog Number
- 952039 FDA UDI
- Primary DI / UDI-DI
- 06438153000327 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438153BU0001138F EUDAMED
- Direct Marketing DI
- 06438153000327 EUDAMED
- FDA Product Code
- LXG 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 I FDA UDI
- Regulation Number
- 862.2050 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Decapper Flex, TCA by Thermo Fisher Scientific Oy — 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 | 6438153BU0001138F | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific Oy
- EUDAMED SRN
- FI-MF-000001479
Sources (2)
- EUDAMED 7db98863-4201-4d9a-99cf-63e9121be4ab 61 fields · synced Jul 27, 2026
- FDA UDI 7b66e4f9-8b1a-42a8-b309-a9d867f2656d 34 fields · synced May 30, 2026