Identity
- Trade Name
- ProTube FDA UDI
- Generic Name
- Specimen information management system IVD FDA UDI
- Device Name
- The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out. FDA UDI
- Model / Reference
- PTB FDA UDI
- Description
- The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640172343005 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Specimen information management system IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Specimen information management system IVD
ProTube by Inpeco SA — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Inpeco SA
Sources (2)
- FDA UDI e40cc2db-0b0c-4568-9b68-1ef6271706b3 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026