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Formthotics

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FM01-OrDmB-Rb-Y1Ref FM01-OrDmB-Rb-Y2Ref FM01-OrDmB-Rb-Y3

by Foot Science International Limited

Identity

Trade Name
Formthotics EUDAMEDFDA UDI
Generic Name
Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Orthotic insole, prefabricated, antimicrobial FDA UDI
Device Name
Formthotics Foot Orthotic Insole EUDAMED
3D Tri-plane Rearfoot Wedge S.A - S FDA UDI
Medical Original Dual Ultra XS FDA UDI
Formthotics Medical Original Single Medium - XXL FDA UDI
Formthotics Medical Original Single Hard - S FDA UDI
Medium Extended Wedges Plain - L FDA UDI
Formthotics Medical Cycle Single Firm - L FDA UDI
Hard Arch Pads Self Adhesive - L FDA UDI
Hard Arch Pads Plain - S FDA UDI
Formthotics Medical Cycle Single Firm - XXL FDA UDI
Firm Rearfoot Wedges Plain - S FDA UDI
Formthotics Medical Original Single Medium - M FDA UDI
Formthotics Medical Original Single Soft - XXS FDA UDI
3D Heel Raisers Self Adhesive - S FDA UDI
Formthotics Medical Original Single Medium - Y3 FDA UDI
Formthotics Medical Wide Fit Dual Medium - XS FDA UDI
3D Tri-plane Rearfoot Wedge S.A - L FDA UDI
Wedged Strip Blue Adh S FDA UDI
Hard Arch Pads Self Adhesive - S FDA UDI
Medium Extended Wedges Self Adhesive - S FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf)- XXL FDA UDI
Medical Original Dual Ultra L FDA UDI
Medium Extended Wedges Self Adhesive - L FDA UDI
Hard Arch Pads Plain - M FDA UDI
Medical Original Dual Ultra M FDA UDI
High Heel Raisers Plain - M FDA UDI
Firm Rearfoot Wedges Plain - M FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf) - XS FDA UDI
Formthotics Medical Original Single X Soft - XL FDA UDI
Medium Extended Wedges Plain - S FDA UDI
Medical Original Single Ultra L FDA UDI
Metatarsal Domes Black Self Adhesive - 2 FDA UDI
Hard Arch Pads Plain - L FDA UDI
Medical Original Dual Ultra S FDA UDI
Formthotics Medical Cycle Single Firm - S FDA UDI
Firm Extended Wedges Plain - L FDA UDI
Medical Original Dual Ultra 2L FDA UDI
Formthotics Medical Original ShockStop - XS FDA UDI
Formthotics Medical Original Single Soft - M FDA UDI
3D Reversible Forefoot Wedge S.A - M FDA UDI
Formthotics Medical Original Single Medium - XS FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf) - S FDA UDI
High Heel Raisers Self Adhesive - M FDA UDI
Formthotics Medical Cycle Single Firm - XXS FDA UDI
Medium Rearfoot Wedges Plain - M FDA UDI
Formthotics Medical Cycle Single Firm - M FDA UDI
Formthotics Medical Original Single Soft - XL FDA UDI
Formthotics Medical Original Single Soft - L FDA UDI
Formthotics Medical Original Single Hard - XL FDA UDI
Model / Reference
FM01-OrDmB-Rb-Y1 EUDAMED
FM01-OrDmB-Rb-Y2 EUDAMED
FM01-OrDmB-Rb-Y3 EUDAMED
3d-01-TrwSa-Or-S FDA UDI
FM01-OrDuA-Pn-XS FDA UDI
FM01-OrSmA-Bl-2L FDA UDI
FM01-OrShA-Re-SM FDA UDI
A-01-EwPl-Bl-L FDA UDI
FM01-SCSfB-Bk-LA FDA UDI
A-01-ApSa-Re-L FDA UDI
A-01-ApPl-Re-S FDA UDI
FM01-SCSfA-Bk-2L FDA UDI
A-01-RwPl-Bk-S FDA UDI
FM01-OrSmA-Bl-ME FDA UDI
FM01-OrSsA-Bu-2S FDA UDI
3d-01-HrSa-Re-S FDA UDI
FM01-OrSmB-Bl-Y3 FDA UDI
FM01-WfDmA-Gg-XS FDA UDI
3d-01-TrwSa-Or-L FDA UDI
A-01-WsSa-Bl-S FDA UDI
A-01-ApSa-Re-S FDA UDI
A-01-EwSa-Bl-S FDA UDI
FM01-SfDmApGg-2L FDA UDI
FM01-OrDuA-Pn-LA FDA UDI
A-01-EwSa-Bl-L FDA UDI
A-01-ApPl-Re-M FDA UDI
FM01-OrDuA-Pn-ME FDA UDI
A-01-6mPl-Re-M FDA UDI
A-01-RwPl-Bk-M FDA UDI
FM01-SfDmBpGg-XS FDA UDI
FM01-OrXsA-Be-XL FDA UDI
A-01-EwPl-Bl-S FDA UDI
FM01-OrSuA-Na-LA FDA UDI
A-01-MdSa-Bk-2 FDA UDI
A-01-ApPl-Re-L FDA UDI
FM01-OrDuA-Pn-SM FDA UDI
FM01-SCSfB-Bk-SM FDA UDI
A-01-EwPl-Bk-L FDA UDI
FM01-OrDuA-Pn-2L FDA UDI
FM01-OrSpA-Cb-XS FDA UDI
FM01-OrSsA-Bu-ME FDA UDI
3d-01-RFwSa-Gr-M FDA UDI
FM01-OrSmA-Bl-XS FDA UDI
FM01-SfDmBpGg-SM FDA UDI
A-01-6mSa-Re-M FDA UDI
FM01-SCSfB-Bk-2S FDA UDI
A-01-RwPl-Bl-M FDA UDI
FM01-SCSfB-Bk-ME FDA UDI
FM01-OrSsA-Bu-XL FDA UDI
FM01-OrSsA-Bu-LA FDA UDI
FM01-OrShA-Re-XL FDA UDI
Description
3D Tri-plane Rearfoot Wedge S.A - S FDA UDI
Medical Original Dual Ultra XS FDA UDI
Formthotics Medical Original Single Medium - XXL FDA UDI
Formthotics Medical Original Single Hard - S FDA UDI
Medium Extended Wedges Plain - L FDA UDI
Formthotics Medical Cycle Single Firm - L FDA UDI
Hard Arch Pads Self Adhesive - L FDA UDI
Hard Arch Pads Plain - S FDA UDI
Formthotics Medical Cycle Single Firm - XXL FDA UDI
Firm Rearfoot Wedges Plain - S FDA UDI
Formthotics Medical Original Single Medium - M FDA UDI
Formthotics Medical Original Single Soft - XXS FDA UDI
3D Heel Raisers Self Adhesive - S FDA UDI
Formthotics Medical Original Single Medium - Y3 FDA UDI
Formthotics Medical Wide Fit Dual Medium - XS FDA UDI
3D Tri-plane Rearfoot Wedge S.A - L FDA UDI
Wedged Strip Blue Adh S FDA UDI
Hard Arch Pads Self Adhesive - S FDA UDI
Medium Extended Wedges Self Adhesive - S FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf)- XXL FDA UDI
Medical Original Dual Ultra L FDA UDI
Medium Extended Wedges Self Adhesive - L FDA UDI
Hard Arch Pads Plain - M FDA UDI
Medical Original Dual Ultra M FDA UDI
High Heel Raisers Plain - M FDA UDI
Firm Rearfoot Wedges Plain - M FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf) - XS FDA UDI
Formthotics Medical Original Single X Soft - XL FDA UDI
Medium Extended Wedges Plain - S FDA UDI
Medical Original Single Ultra L FDA UDI
Metatarsal Domes Black Self Adhesive - 2 FDA UDI
Hard Arch Pads Plain - L FDA UDI
Medical Original Dual Ultra S FDA UDI
Formthotics Medical Cycle Single Firm - S FDA UDI
Firm Extended Wedges Plain - L FDA UDI
Medical Original Dual Ultra 2L FDA UDI
Formthotics Medical Original ShockStop - XS FDA UDI
Formthotics Medical Original Single Soft - M FDA UDI
3D Reversible Forefoot Wedge S.A - M FDA UDI
Formthotics Medical Original Single Medium - XS FDA UDI
Formthotics Medical SlimFit Dual Medium (Perf) - S FDA UDI
High Heel Raisers Self Adhesive - M FDA UDI
Formthotics Medical Cycle Single Firm - XXS FDA UDI
Medium Rearfoot Wedges Plain - M FDA UDI
Formthotics Medical Cycle Single Firm - M FDA UDI
Formthotics Medical Original Single Soft - XL FDA UDI
Formthotics Medical Original Single Soft - L FDA UDI
Formthotics Medical Original Single Hard - XL FDA UDI

Identifiers

Primary DI / UDI-DI
09419430011462 EUDAMED
09419430011479 EUDAMED
09419430011530 EUDAMED
09419430012261 FDA UDI
09419430001128 FDA UDI
09419430003061 FDA UDI
09419430003108 FDA UDI
09419430004235 FDA UDI
09419430011783 FDA UDI
09419430004266 FDA UDI
09419430004273 FDA UDI
09419430011806 FDA UDI
09419430003948 FDA UDI
09419430003030 FDA UDI
09419430003306 FDA UDI
09419430012209 FDA UDI
09419430007922 FDA UDI
09419430003528 FDA UDI
09419430012285 FDA UDI
09419430004495 FDA UDI
09419430004242 FDA UDI
09419430004181 FDA UDI
09419430002507 FDA UDI
09419430001159 FDA UDI
09419430004204 FDA UDI
09419430004280 FDA UDI
09419430001142 FDA UDI
09419430004105 FDA UDI
09419430003955 FDA UDI
09419430002453 FDA UDI
09419430006857 FDA UDI
09419430004211 FDA UDI
09419430001210 FDA UDI
09419430004334 FDA UDI
09419430004297 FDA UDI
09419430001135 FDA UDI
09419430011769 FDA UDI
09419430003993 FDA UDI
09419430001173 FDA UDI
09419430003450 FDA UDI
09419430003337 FDA UDI
09419430012391 FDA UDI
09419430003016 FDA UDI
09419430002460 FDA UDI
09419430004075 FDA UDI
09419430011745 FDA UDI
09419430004167 FDA UDI
09419430011776 FDA UDI
09419430003351 FDA UDI
09419430003344 FDA UDI
09419430003139 FDA UDI
Basic UDI-DI
941943000001C2 EUDAMED
FDA Product Code
IQI FDA UDI
EMDN Code
Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
GMDN Term
Orthotic insole, prefabricated, non-antimicrobial FDA UDI
Orthotic insole, prefabricated, antimicrobial FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
890.3475 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthotic insole, prefabricated, non-antimicrobial

Formthotics by Foot Science International Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthotic insole, prefabricated, non-antimicrobial.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Foot Science International Limited
EUDAMED SRN
NZ-MF-000044443
Authorised Representative
Advena Limited MT-AR-000000234

Sources (51)

  • EUDAMED d89a1b77-f80b-4620-ae44-b55523a9294e 61 fields · synced Oct 5, 2026
  • EUDAMED 082b215b-8b57-4ba1-9786-e36702c02305 61 fields · synced May 17, 2026
  • EUDAMED c4187472-2ddc-4e6f-b34e-c55bf547fb84 61 fields · synced May 17, 2026
  • FDA UDI 26dfe496-12d4-403b-9e68-647ef8ccea1e 33 fields · synced May 26, 2026
  • FDA UDI c7d1e5af-644d-4223-a5bc-a3df7d3e6352 33 fields · synced May 29, 2026
  • FDA UDI 5fc6cb10-389e-479c-b561-0f2d2dfc3f04 33 fields · synced May 29, 2026
  • FDA UDI 3e76153b-afba-41c4-8e7b-b91a1278bd01 33 fields · synced May 29, 2026
  • FDA UDI 5167b4ad-ed75-43d7-a4b6-19db66263006 33 fields · synced May 29, 2026
  • FDA UDI 6378b135-e44d-472c-96b9-7ec604becc62 33 fields · synced May 29, 2026
  • FDA UDI 28088ae5-cc23-4933-8925-fd9434f02db4 33 fields · synced May 29, 2026
  • FDA UDI c5f14297-953d-4bec-9aea-c86e7de6a420 33 fields · synced May 29, 2026
  • FDA UDI ca007f01-34e5-453b-b413-381c020ab461 33 fields · synced May 29, 2026
  • FDA UDI 54d2be64-6af7-417b-a955-6d4fa488cfc3 33 fields · synced May 29, 2026
  • FDA UDI 4016b30e-166f-4d1d-831a-13a060882144 33 fields · synced May 29, 2026
  • FDA UDI 739f6b79-c249-4faa-a842-18ffb3ea11e0 33 fields · synced May 29, 2026
  • FDA UDI 72d4c06d-de27-4551-98ba-56333530fd8d 33 fields · synced May 29, 2026
  • FDA UDI 83b510a0-1553-4241-9067-51bd1b97e2d8 33 fields · synced May 30, 2026
  • FDA UDI 1434d18f-b04d-4bff-873f-a527c7987b24 33 fields · synced May 30, 2026
  • FDA UDI c429e7a6-b7ee-4a5d-bed6-dd8e492bf369 33 fields · synced May 30, 2026
  • FDA UDI c989fa87-670e-4c8c-8d53-586dc5b171e0 33 fields · synced May 30, 2026
  • FDA UDI ddf0fdfb-b7b6-4bb7-ac4a-3106205d50c5 33 fields · synced May 30, 2026
  • FDA UDI 76f83592-44f2-4a78-bc7b-3b3761d7d07d 33 fields · synced May 30, 2026
  • FDA UDI 0ee85575-643e-4789-a1c4-f09c4735c0f4 33 fields · synced May 30, 2026
  • FDA UDI e30e3216-4368-4739-843c-c1913cd031fd 33 fields · synced May 30, 2026
  • FDA UDI 964ac235-bf08-4db4-9575-15dab3459f4a 33 fields · synced May 30, 2026
  • FDA UDI d93d21c2-5814-4ba3-abe2-cc4c3ebfc96f 33 fields · synced May 30, 2026
  • FDA UDI 291f81a5-781b-4c80-a31d-bc57e596cd6b 33 fields · synced May 30, 2026
  • FDA UDI 52f7935d-4574-48b8-8f55-907c4f760f37 33 fields · synced May 30, 2026
  • FDA UDI 62482526-856e-480c-9d9d-88ba08a48221 33 fields · synced May 30, 2026
  • FDA UDI 5540adac-8a6e-4d9e-bb8c-b13765cdf5cd 33 fields · synced May 30, 2026
  • FDA UDI a9d649f8-41fa-4950-b2c3-050366c32e2f 33 fields · synced May 30, 2026
  • FDA UDI 37006db2-619f-4721-87ba-56c76f93eab2 33 fields · synced May 30, 2026
  • FDA UDI 056d0708-a077-4eff-aa48-c0f22f1b8c27 33 fields · synced May 30, 2026
  • FDA UDI 463cce67-c4d9-4e28-ab0a-14d27f4cb6a3 33 fields · synced May 30, 2026
  • FDA UDI d36586d5-fdee-41cd-9187-93428fa43673 33 fields · synced May 30, 2026
  • FDA UDI 5db3ab77-08ca-494e-a78a-e2f9278f22fd 33 fields · synced May 30, 2026
  • FDA UDI 5292c35c-f125-47c1-8a10-e0ef03d3ad0e 33 fields · synced May 30, 2026
  • FDA UDI 0e4cc0e4-181a-42e3-a9a4-cf2987cc2d3b 33 fields · synced May 30, 2026
  • FDA UDI f010d8eb-ca80-486c-a4a2-d5b9dbf2fee3 33 fields · synced May 30, 2026
  • FDA UDI 1e447b45-ded1-4b41-9b78-71d682bad017 33 fields · synced May 30, 2026
  • FDA UDI 0d94ef50-4dc6-4fe0-a062-967f7f7b405c 33 fields · synced May 30, 2026
  • FDA UDI 5b7be403-0740-44c7-b893-afdedef07c0b 33 fields · synced May 30, 2026
  • FDA UDI 8af1ad21-f6ce-4b46-8166-7419b01659ae 33 fields · synced May 30, 2026
  • FDA UDI ac7d328d-4084-47c3-97fe-fc66faa8ca04 33 fields · synced May 30, 2026
  • FDA UDI ff00bfb5-8632-42cc-b2d7-e158990712ef 33 fields · synced May 30, 2026
  • FDA UDI f85d05d4-952c-43ea-b44f-45ab00480bcd 33 fields · synced May 30, 2026
  • FDA UDI 6d719fb4-fb7e-4c04-89bf-bc3153ac5589 33 fields · synced May 30, 2026
  • FDA UDI 1ae6dcce-a0a5-4291-a6f8-b2ecb7d825b7 33 fields · synced May 30, 2026
  • FDA UDI e30ad722-3196-48cf-ae03-f7186a3e34c6 33 fields · synced May 30, 2026
  • FDA UDI 7b68cabc-8a27-4e6b-aca6-06408bcda90a 33 fields · synced May 30, 2026
  • FDA UDI 4ca24219-2ed2-4503-8903-254fee9451e2 33 fields · synced May 30, 2026