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Insollz
EUDAMEDClass I (EU MDR)
Ref STD-9/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-9/FL/MD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061038020106 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
Insollz by Insollz Ltd — 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 | 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 7118872f-61bf-41c5-99db-ed7e4739b4d2 61 fields · synced Jun 19, 2026