Identity
- Model / Reference
- HEEL ORTO EUDAMED1498C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907684214981 EUDAMED
- Basic UDI-DI
- 59076842HEELORTOAC EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
1498c by IRR spółka z ograniczoną odpowiedzialnością — 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 | 59076842HEELORTOAC | Class I | Active |
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Manufacturer
- Manufacturer
- IRR spółka z ograniczoną odpowiedzialnością
- EUDAMED SRN
- PL-MF-000024038
Sources (1)
- EUDAMED d16be7e8-f167-409d-b0ad-b1ed5dcad45e 61 fields · synced Oct 6, 2026