Identity
- Trade Name
- ProTube EUDAMEDFDA UDI
- Generic Name
- Specimen information management system IVD FDA UDI
- Device Name
- ProTube EUDAMEDProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters. FDA UDI
- Model / Reference
- PTB EUDAMEDFDA UDI
- Description
- ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640172343012 EUDAMEDFDA UDI
- Basic UDI-DI
- 764017234PTBL4 EUDAMED
- Direct Marketing DI
- 07640172343012 EUDAMED
- FDA Product Code
- JQP FDA UDI
- EMDN Code
- W0299 IVD INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Specimen information management system IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Market of Registration
- Italy 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
ProTube 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 | 764017234PTBL4 | 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 72473612-0919-43be-9d50-9d50393d0575 61 fields · synced Jul 14, 2026
- FDA UDI 47b90ebc-8674-4963-9651-eead933481ab 33 fields · synced May 30, 2026