Identity
- Trade Name
- Hælindlæg Large EUDAMED
- Model / Reference
- Indlægssåler EUDAMED845445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05719808454452 EUDAMED
- Basic UDI-DI
- 5719808insoleB5 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Hælindlæg Large by tacco international nv — 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 | 5719808insoleB5 | Class I | Active |
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Manufacturer
- Manufacturer
- tacco international nv
- EUDAMED SRN
- BE-MF-000042561
Sources (1)
- EUDAMED a2e8d70b-8da2-4ee7-b182-7b4b67c51b20 61 fields · synced Oct 6, 2026