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Insollz
EUDAMEDClass I (EU MDR)
Ref STD-11/FL/MDModel Standard Insollz Size 3 Full Length Medium Density
by Insollz Ltd
Identity
- Trade Name
- Insollz EUDAMED
- Model / Reference
- Standard Insollz Size 3 Full Length Medium Density EUDAMEDSTD-11/FL/MD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061038020120 EUDAMED
- Basic UDI-DI
- 506103802INZ-CORE-2026KR EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Insollz by Insollz Ltd — 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 | 506103802INZ-CORE-2026KR | Class I | Active |
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Manufacturer
- Manufacturer
- Insollz Ltd
- EUDAMED SRN
- UK-MF-000052004
- Authorised Representative
- Insollz (IRL) Limited IE-AR-000050918
Sources (1)
- EUDAMED e4a03f8c-8295-4ff6-a95e-65d657f554f0 61 fields · synced Jun 18, 2026