Next Prp Syringe
EUDAMEDFDA UDIClass IIb (EU MDR)
by T-Bi̇yoteknoloji̇ Laboratuvar Esteti̇k Medi̇kal Kozmeti̇k San. Ti̇c. Ltd. Şti̇.
Identity
- Trade Name
- NEXT PRP SYRINGE EUDAMEDNext PRP FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- NEXT PRP SYRINGE EUDAMEDFDA UDI
- Model / Reference
- N 500 EUDAMEDN500 FDA UDI
- Description
- Next PRP Syringe FDA UDI
Identifiers
- Catalog Number
- N500 FDA UDI
- Primary DI / UDI-DI
- 08681092003111 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08681092003111 EUDAMED
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Device sterilization/disinfection container, reusable
Next Prp Syringe by T-Bi̇yoteknoloji̇ Laboratuvar Esteti̇k Medi̇kal Kozmeti̇k San. Ti̇c. Ltd. Şti̇. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08681092003111 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- EUDAMED SRN
- TR-MF-000016403
Sources (2)
- EUDAMED 47552865-35ff-4188-b324-dbc36d1fc448 61 fields · synced Jun 19, 2026
- FDA UDI 0f4d60b5-3ed8-492b-a310-2211775688e2 35 fields · synced May 29, 2026