Identity
- Trade Name
- Selphyl PRP Tube FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- SELPHYL PRP Tube EUDAMEDBlood separation tube for PRP FDA UDI
- Model / Reference
- 0363 EUDAMEDFDA UDI
- Description
- Blood separation tube for PRP FDA UDI
Identifiers
- Catalog Number
- 0363 FDA UDI
- Primary DI / UDI-DI
- 00851802007113 EUDAMEDFDA UDI
- Basic UDI-DI
- 08518020070L9 EUDAMED
- Direct Marketing DI
- 00851802007113 EUDAMED
- FDA Product Code
- ORG FDA UDI
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 9 Milliliter FDA UDI
SELPHYL PRP Tube by Factor Medical Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08518020070L9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Factor Medical Inc.
- EUDAMED SRN
- US-MF-000041642
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 49bede58-af03-4528-b325-c9874ad17b63 61 fields · synced Jul 25, 2026
- FDA UDI b60e65f6-1339-4a70-bac7-08e032f932d8 38 fields · synced May 29, 2026