Identity
- Trade Name
- Sepax RM FDA UDI
- Generic Name
- Blood centrifugation system processing unit FDA UDI
- Model / Reference
- Sepax RM FDA UDI
Identifiers
- Catalog Number
- 14100 FDA UDI
- Primary DI / UDI-DI
- 07640125650594 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Blood centrifugation system processing unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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: Blood centrifugation system processing unit
Sepax RM by Biosafe S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood centrifugation system processing unit.
- Sepax 2 — Biosafe S.A. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biosafe S.A.
Sources (1)
- FDA UDI 9cf6e456-e876-49b8-9124-70c6081e333a 34 fields · synced May 31, 2026