Identity
- Trade Name
- HY-TISSUE PRP 20 EUDAMED
- Device Name
- HY-TISSUE PRP 20 EUDAMED
- Model / Reference
- TP02-01-20 EUDAMED13001196 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055267241057 EUDAMED
- Basic UDI-DI
- 80336618005020100000000QQ EUDAMED
- EMDN Code
- B06 CELLULAR OR BIOLOGICAL MANIPULATION DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Hy-Tissue Prp 20 by Fidia Farmaceutici S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80336618005020100000000QQ | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fidia Farmaceutici S.p.A.
- EUDAMED SRN
- IT-MF-000026988
Sources (1)
- EUDAMED 97057690-c730-4e58-99e8-d21661098080 61 fields · synced Jul 9, 2026