Identity
- Trade Name
- Boni EUDAMED
- Device Name
- Gauzes EUDAMED
- Model / Reference
- 80-0100 / 80-0101 / 80-0200 EUDAMEDBON-346094 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05400141339864 EUDAMED
- Basic UDI-DI
- 48079990API094NJ EUDAMED
- EMDN Code
- M020204 NON-WOVEN GAUZES IN PIECES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Boni by Aso Philippines, Inc. — Class I — 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 | 48079990API094NJ | Class I | Active |
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Manufacturer
- Manufacturer
- Aso Philippines, Inc.
- EUDAMED SRN
- PH-MF-000027714
- Authorised Representative
- Aso Europe BV NL-AR-000004377
Sources (1)
- EUDAMED 0c1710ae-f4d8-4960-9352-1dfd7725c7da 61 fields · synced Jun 18, 2026