Identity
- Trade Name
- Flawa Aqua EUDAMED
- Device Name
- PU Waterproof adhesive bandages EUDAMED
- Model / Reference
- LR-145555 / 145 555 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08717438376042 EUDAMED
- Basic UDI-DI
- 48079990API055N8 EUDAMED
- EMDN Code
- M0599 MEDICAL PLASTERS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Flawa Aqua 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 | 48079990API055N8 | 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 ff0f0024-69ec-4cc2-943c-729425a8cc1d 61 fields · synced Jul 30, 2026