Identity
- Device Name
- RegenWound-HA Set EUDAMED
- Model / Reference
- RW-HA-SET EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640138982026 EUDAMED
- Basic UDI-DI
- 764013898RGWOUND5H EUDAMED
- EMDN Code
- B0599 TOPICAL USE BLOOD COMPONENTS PREPARATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Set for the safe preparation of autologous RegenPRP™ and subsequent wound dressing EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
RegenWound-HA Set by Regen Lab Sa — Class IIb — 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 | 764013898RGWOUND5H | Class IIb | Active |
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Manufacturer
- Manufacturer
- Regen Lab SA
- EUDAMED SRN
- CH-PR-000049402
Sources (1)
- EUDAMED aef61f08-7b14-409f-9470-f9933e6fd7ab 61 fields · synced Jul 8, 2026