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Insollz
EUDAMEDClass I (EU MDR)
Ref CMF-3/FL/MDModel Comfort Insollz Size 3 Full Length Medium DensityRef METBAR-6/FL/MDModel Insollz Metatarsal Bar Model Size 3 Full Length Medium DensityRef LUX-6/FL/MDModel Insollz Lux Model Size 3 Full Length Medium DensityRef STD-8/FL/HDModel Insollz Standard Model Size 3 Full Length HIGH DensityRef METDOME-12/FL/MDModel Insollz Metatarsal Dome Model Size 3 Full Length Medium DensityRef CMF-5/FL/MDRef CMF-12/FL/MDRef STD-4/FL/MDModel Standard Insollz Size 3 Full Length Medium DensityRef METBAR-8/FL/MDRef CMF-4/FL/MDRef METDOME-10/FL/MDRef CMF-7/FL/MDRef METDOME-7/FL/MDRef STD-5/FL/MDRef METBAR-5/FL/MDRef METDOME-11/FL/MDRef CMF-8/FL/MDRef CMF+7/FL/MDModel Insollz Comfort + Model Size 3 Full Length Medium DensityRef METBAR-10/FL/MDRef STD-10/FL/MDRef LUX-11/FL/MDRef CMF-6/FL/MDRef STD-10/FL/HDRef CMF-11/FL/MDRef METBAR-9/FL/MDRef METDOME-4/FL/MDRef CMF-9/FL/MDRef STD-3/FL/HDRef METDOME-5/FL/MDRef STD-11/FL/HDRef STD-4/FL/HDRef STD-5/FL/HDRef METBAR-4/FL/MDRef STD-7/FL/MDRef METBAR-12/FL/MDRef METDOME-8/FL/MDRef LUX-5/FL/MDRef METBAR-3/FL/MDRef METDOME-6/FL/MDRef LUX-9/FL/MDRef STD-12/FL/MDRef CMF+11/FL/MD
by Insollz Ltd
Identity
- Trade Name
- Insollz EUDAMED
- Model / Reference
- Comfort Insollz Size 3 Full Length Medium Density EUDAMEDCMF-3/FL/MD EUDAMEDInsollz Metatarsal Bar Model Size 3 Full Length Medium Density EUDAMEDMETBAR-6/FL/MD EUDAMEDInsollz Lux Model Size 3 Full Length Medium Density EUDAMEDLUX-6/FL/MD EUDAMEDInsollz Standard Model Size 3 Full Length HIGH Density EUDAMEDSTD-8/FL/HD EUDAMEDInsollz Metatarsal Dome Model Size 3 Full Length Medium Density EUDAMEDMETDOME-12/FL/MD EUDAMEDCMF-5/FL/MD EUDAMEDCMF-12/FL/MD EUDAMEDStandard Insollz Size 3 Full Length Medium Density EUDAMEDSTD-4/FL/MD EUDAMEDMETBAR-8/FL/MD EUDAMEDCMF-4/FL/MD EUDAMEDMETDOME-10/FL/MD EUDAMEDCMF-7/FL/MD EUDAMEDMETDOME-7/FL/MD EUDAMEDSTD-5/FL/MD EUDAMEDMETBAR-5/FL/MD EUDAMEDMETDOME-11/FL/MD EUDAMEDCMF-8/FL/MD EUDAMEDInsollz Comfort + Model Size 3 Full Length Medium Density EUDAMEDCMF+7/FL/MD EUDAMEDMETBAR-10/FL/MD EUDAMEDSTD-10/FL/MD EUDAMEDLUX-11/FL/MD EUDAMEDCMF-6/FL/MD EUDAMEDSTD-10/FL/HD EUDAMEDCMF-11/FL/MD EUDAMEDMETBAR-9/FL/MD EUDAMEDMETDOME-4/FL/MD EUDAMEDCMF-9/FL/MD EUDAMEDSTD-3/FL/HD EUDAMEDMETDOME-5/FL/MD EUDAMEDSTD-11/FL/HD EUDAMEDSTD-4/FL/HD EUDAMEDSTD-5/FL/HD EUDAMEDMETBAR-4/FL/MD EUDAMEDSTD-7/FL/MD EUDAMEDMETBAR-12/FL/MD EUDAMEDMETDOME-8/FL/MD EUDAMEDLUX-5/FL/MD EUDAMEDMETBAR-3/FL/MD EUDAMEDMETDOME-6/FL/MD EUDAMEDLUX-9/FL/MD EUDAMEDSTD-12/FL/MD EUDAMEDCMF+11/FL/MD EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05061038020250 EUDAMED05061038020564 EUDAMED05061038020489 EUDAMED05061038020205 EUDAMED05061038020786 EUDAMED05061038020274 EUDAMED05061038020335 EUDAMED05061038020052 EUDAMED05061038020588 EUDAMED05061038020267 EUDAMED05061038020830 EUDAMED05061038020342 EUDAMED05061038020748 EUDAMED05061038020069 EUDAMED05061038020557 EUDAMED05061038020779 EUDAMED05061038020298 EUDAMED05061038020397 EUDAMED05061038020601 EUDAMED05061038020113 EUDAMED05061038020533 EUDAMED05061038020281 EUDAMED05061038020229 EUDAMED05061038020328 EUDAMED05061038020595 EUDAMED05061038020724 EUDAMED05061038020304 EUDAMED05061038020151 EUDAMED05061038020809 EUDAMED05061038020236 EUDAMED05061038020168 EUDAMED05061038020175 EUDAMED05061038020649 EUDAMED05061038020083 EUDAMED05061038020625 EUDAMED05061038020755 EUDAMED05061038020472 EUDAMED05061038020632 EUDAMED05061038020816 EUDAMED05061038020519 EUDAMED05061038020137 EUDAMED05061038020434 EUDAMED
- Basic UDI-DI
- 506103802INZ-COMFORTBU EUDAMED506103802INZ-METBARJP EUDAMED506103802INZ-LUXAF EUDAMED506103802INZ-STDHIGHDENRJ EUDAMED506103802INZ-METDOMEDN EUDAMED506103802INZ-CORE-2026KR EUDAMED506103802INZ-COMFORT+8L 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-COMFORTBU | 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 (42)
- EUDAMED 9d062524-7376-43f9-b329-d5a327aece83 61 fields · synced Sep 18, 2026
- EUDAMED 5a341b82-1a97-4c64-af17-9f89c656dca2 61 fields · synced May 16, 2026
- EUDAMED 691d3c56-216d-467e-a786-d9955b49c931 61 fields · synced May 16, 2026
- EUDAMED e994e7f4-4133-4424-8506-aa8cc0e212ee 61 fields · synced May 16, 2026
- EUDAMED f757f611-39eb-45af-9982-c131f8731799 61 fields · synced May 16, 2026
- EUDAMED 7f0068d9-22d4-477e-ba1c-3c1fa2ae48c9 61 fields · synced May 16, 2026
- EUDAMED e9545159-b68b-4e18-92bf-fe586a775240 61 fields · synced May 16, 2026
- EUDAMED f5a1d470-2c36-4a63-871b-8cb77bf4aaeb 61 fields · synced May 17, 2026
- EUDAMED e08bec46-51f2-4c91-ac0a-412b1822a8ac 61 fields · synced May 17, 2026
- EUDAMED 1055adbe-aa2a-43fd-b955-5ea36401c55b 61 fields · synced May 17, 2026
- EUDAMED f8814e64-f666-4006-baf1-24c0627b265f 61 fields · synced May 17, 2026
- EUDAMED 2cb73107-cc9a-404b-aac9-98b26d78ba38 61 fields · synced May 17, 2026
- EUDAMED ebf27966-af9f-43a0-9231-dbb4b690dd6d 61 fields · synced May 17, 2026
- EUDAMED 458a9dda-0ed3-4271-86ca-7dcdda6ad9b6 61 fields · synced May 17, 2026
- EUDAMED 5d622328-0704-4178-8774-dcb21954ee2a 61 fields · synced May 17, 2026
- EUDAMED 891f9979-eb55-4063-b3c5-77d1b91439a4 61 fields · synced May 17, 2026
- EUDAMED b040acaf-e967-4a65-992a-9ea1c24d92cf 61 fields · synced May 17, 2026
- EUDAMED de9f51ba-7c1d-4ee5-9477-6c6ac5a1b84a 61 fields · synced May 17, 2026
- EUDAMED 1ddff970-ecab-4ccc-acb0-ee9fc40e48d4 61 fields · synced May 17, 2026
- EUDAMED 62c75712-a6da-42bc-8f4b-cfcdcc76735d 61 fields · synced May 17, 2026
- EUDAMED e433ce27-d41b-4230-bf38-707ffbde4a95 61 fields · synced May 17, 2026
- EUDAMED 0ac52450-c2ef-4827-b2a2-0ef26df981b5 61 fields · synced May 17, 2026
- EUDAMED 6e9ef0ee-f49d-4b54-b85e-fce71bf83120 61 fields · synced May 17, 2026
- EUDAMED 531e5586-7e76-4e30-a8d1-9a22dd68406e 61 fields · synced May 18, 2026
- EUDAMED baa32d4c-3d61-4695-9a52-ce6a7b85f247 61 fields · synced May 18, 2026
- EUDAMED dfa9539f-238a-4ad1-b29e-1be5939f84b0 61 fields · synced May 18, 2026
- EUDAMED b7b6f4b1-8547-4c30-b35d-271f1adb3c4f 61 fields · synced May 18, 2026
- EUDAMED 899680d6-c7a5-4f63-9470-f88227f4d43f 61 fields · synced May 18, 2026
- EUDAMED 8a0b841b-39e5-4a67-986a-72a8d08245f6 61 fields · synced May 18, 2026
- EUDAMED 74d0aa2a-8bb7-49db-9868-960ea1902ee9 61 fields · synced May 18, 2026
- EUDAMED 428485b5-f18f-4b44-ae70-684a67e7de63 61 fields · synced May 18, 2026
- EUDAMED 81458a8b-615c-4d66-9419-cc768e1a5c33 61 fields · synced May 18, 2026
- EUDAMED 4f793c8f-998a-4f55-a7e1-b6d2dfcdf960 61 fields · synced May 18, 2026
- EUDAMED 5fa25b44-a7ab-4ec4-aab4-c7d88985478e 61 fields · synced May 18, 2026
- EUDAMED ff9f0648-ceba-490c-ada7-53967d70ff34 61 fields · synced May 18, 2026
- EUDAMED 229c05a3-c03d-4570-8aa4-b3c050b0b87f 61 fields · synced May 19, 2026
- EUDAMED d753aa5c-36d1-4fd8-a024-f0d6d2bc49ea 61 fields · synced May 19, 2026
- EUDAMED 28a6767f-ba59-4130-87e8-72189613ad28 61 fields · synced May 19, 2026
- EUDAMED 1538b031-3b24-4503-83d9-48fe770dd235 61 fields · synced May 19, 2026
- EUDAMED f9dda8c3-ab88-44ce-a9f1-e469a5b98d05 61 fields · synced May 19, 2026
- EUDAMED d821688b-eaef-4030-8220-16440e10f0e1 61 fields · synced May 19, 2026
- EUDAMED 4a175464-d76b-46d2-938b-24d9f446d334 61 fields · synced May 19, 2026