Identity
- Trade Name
- Bonvadis EUDAMED
- Device Name
- Bonvadis Topical Cream EUDAMED
- Model / Reference
- / EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719883980052 EUDAMED
- Basic UDI-DI
- 471988398BTC012bSQ EUDAMED
- EMDN Code
- M04040501 HYDROGEL DRESSINGS, NON-COMBINED EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
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
Bonvadis by Oneness Biotech Co., Ltd — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251093 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 471988398BTC012bSQ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Oneness Biotech Co., Ltd
- EUDAMED SRN
- TW-MF-000032480
- FDA Applicant
- Oneness Biotech Co., Ltd.
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED b00ce4ab-5fea-43a6-a15c-3694730c90c4 85 fields · synced Jun 18, 2026
- FDA 510(k) K251093 1 fields · synced May 18, 2026