Identity
- Trade Name
- Kruidvat EUDAMED
- Device Name
- Neoprene Bandage Wrist / Ankle / Knee EUDAMED
- Model / Reference
- KV-1119008 V2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08719179627292 EUDAMED
- Basic UDI-DI
- 48079990API081N9 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Orthotic insole, prefabricated, non-antimicrobial
Kruidvat by Aso Philippines, Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 48079990API081N9 | 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 d4004e37-dd62-4999-b515-90d21e3c5351 61 fields · synced Jun 19, 2026