Insollz
Ref CMF+11/FL/MDModel Insollz Comfort + Model Size 3 Full Length Medium Density
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506103802INZ-COMFORT+8L 05061038020434 | Date9 Mar 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- Insollz Comfort + Model Size 3 Full Length Medium Density, CMF+11/FL/MD
- Primary DI / UDI-DI
- 05061038020434
- Basic UDI-DI
- 506103802INZ-COMFORT+8L
- EMDN Code
- Y061203 Orthoses, foot (including insoles and inserts)
- Device Class
- Class I
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- UK-MF-000052004
- Authorised representative
- Insollz (IRL) Limited IE-AR-000050918
Other devices from Insollz Ltd
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No