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Fortuna
EUDAMEDClass I (EU MDR)
Ref FT25HCSModel FT15HRef FT1102XLModel FT1102Ref FT902LModel FT902WRef FTSN022Model FT093ARef FT900SModel FT900ERef FT1471Model FT14WSRef EX903URef FT1467Model FT14ASRef FT093Ref FT1468Ref FT1583Model FT158ARef FT-300-XLModel FT300ARef FT008Model FT0NWSRef EX900MModel EX900ERef FTSN003Model FTSN0BRef EX900XLRef EX1102LModel EX110ARef FT1579Model FT15ESRef FT989Model FT9EHSRef FT097Ref FT1261Model FT12CRef FT900LRef FT1578Ref FT1263Ref FT1581Ref FT007Ref FT1253Model FT12SRef FTSN024Ref FT1257Ref FT991ARef FT1469Ref FT098Ref FT1105XLModel FT1105Ref FT1000MModel FT1000Ref FTSN025Ref FT1000LRef FT1000SRef FT006Ref FT005Ref FT1256Ref EX900SRef FT902XLRef FT1472Ref FT1260Ref FT-300-SRef FT1582Ref FT902SRef FT1102MRef FT1473Ref FT1577
Identity
- Trade Name
- Fortuna EUDAMED
- Device Name
- Reusable Hot Cold Pack EUDAMEDELASTICATED ANKLE SUPPORT EUDAMEDFORTUNA ELASTICATED WRIST SUPPORT EUDAMEDNEOPRENE ANKLE SUPPORT EUDAMEDELASTICATED ELBOW SUPPORT EUDAMEDFORTUNA FEMALE ELASTICATED WRIST SUPPORT EUDAMEDNEOPRENE WRIST SUPPORT/UNIVERSAL EUDAMEDFEMALE ELASTICATED ANKLE SUPPORT EUDAMEDANKLE SUPPORT ELASTICATED SPORTS EUDAMEDELASTICATED ATHLETIC SUPPORT EUDAMEDNEOPRENE WRIST SPLINT EUDAMEDNEOPRENE ELBOW SUPPORT EUDAMEDNEOPRENE BACK SUPPORT EUDAMEDELBOW SUPPORT ELASTICATED SPORTS EUDAMEDELASTICATED HAND SUPPORT EUDAMEDFABRIC GEL TOE CAPS EUDAMEDFEMALE ELASTICATED WRIST SUPPORT EUDAMEDGEL TOE SPREADERS / PROTECTORS / SEPARATORS EUDAMEDELASTICATED CALF SUPPORT EUDAMEDELASTICATED KNEE SUPPORT EUDAMED
- Model / Reference
- FT15H EUDAMEDFT25HCS EUDAMEDFT1102 EUDAMEDFT1102XL EUDAMEDFT902W EUDAMEDFT902L EUDAMEDFT093A EUDAMEDFTSN022 EUDAMEDFT900E EUDAMEDFT900S EUDAMEDFT14WS EUDAMEDFT1471 EUDAMEDEX903U EUDAMEDFT14AS EUDAMEDFT1467 EUDAMEDFT093 EUDAMEDFT1468 EUDAMEDFT158A EUDAMEDFT1583 EUDAMEDFT300A EUDAMEDFT-300-XL EUDAMEDFT0NWS EUDAMEDFT008 EUDAMEDEX900E EUDAMEDEX900M EUDAMEDFTSN0B EUDAMEDFTSN003 EUDAMEDEX900XL EUDAMEDEX110A EUDAMEDEX1102L EUDAMEDFT15ES EUDAMEDFT1579 EUDAMEDFT9EHS EUDAMEDFT989 EUDAMEDFT097 EUDAMEDFT12C EUDAMEDFT1261 EUDAMEDFT900L EUDAMEDFT1578 EUDAMEDFT1263 EUDAMEDFT1581 EUDAMEDFT007 EUDAMEDFT12S EUDAMEDFT1253 EUDAMEDFTSN024 EUDAMEDFT1257 EUDAMEDFT991A EUDAMEDFT1469 EUDAMEDFT098 EUDAMEDFT1105 EUDAMEDFT1105XL EUDAMEDFT1000 EUDAMEDFT1000M EUDAMEDFTSN025 EUDAMEDFT1000L EUDAMEDFT1000S EUDAMEDFT006 EUDAMEDFT005 EUDAMEDFT1256 EUDAMEDEX900S EUDAMEDFT902XL EUDAMEDFT1472 EUDAMEDFT1260 EUDAMEDFT-300-S EUDAMEDFT1582 EUDAMEDFT902S EUDAMEDFT1102M EUDAMEDFT1473 EUDAMEDFT1577 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05031720053965 EUDAMED05031720010128 EUDAMED05031720010036 EUDAMED05031720001249 EUDAMED05031720010135 EUDAMED05031720032939 EUDAMED05031720000679 EUDAMED05031720032892 EUDAMED05031720012443 EUDAMED05031720032908 EUDAMED05031720034339 EUDAMED05031720010203 EUDAMED05031720006282 EUDAMED05031720000648 EUDAMED05031720001058 EUDAMED05031720000662 EUDAMED05031720000617 EUDAMED05031720034292 EUDAMED05031720018445 EUDAMED05031720012986 EUDAMED05031720025160 EUDAMED05031720010159 EUDAMED05031720034285 EUDAMED05031720025184 EUDAMED05031720034315 EUDAMED05031720006275 EUDAMED05031720025085 EUDAMED05031720001263 EUDAMED05031720025122 EUDAMED05031720018469 EUDAMED05031720032915 EUDAMED05031720012993 EUDAMED05031720010289 EUDAMED05031720010067 EUDAMED05031720001270 EUDAMED05031720010074 EUDAMED05031720010050 EUDAMED05031720006268 EUDAMED05031720006251 EUDAMED05031720025115 EUDAMED05031720000631 EUDAMED05031720010043 EUDAMED05031720032946 EUDAMED05031720025153 EUDAMED05031720010173 EUDAMED05031720034322 EUDAMED05031720010012 EUDAMED05031720010104 EUDAMED05031720032953 EUDAMED05031720034278 EUDAMED
- Basic UDI-DI
- 5031720FT15HHQ EUDAMED5031720FT11028L EUDAMED5031720FT902WCM EUDAMED5031720FTSNALP9 EUDAMED5031720FT900EBB EUDAMED5031720FT14WSEM EUDAMED5031720EX903UDK EUDAMED5031720FT14ASCK EUDAMED5031720FT158AAU EUDAMED5031720FT300A9R EUDAMED5031720FT0NWSJB EUDAMED5031720EX900ECA EUDAMED5031720FTSN0BM5 EUDAMED5031720EX110AAF EUDAMED5031720FT15ESD4 EUDAMED5031720FT9EHSHG EUDAMED5031720FT12PHX EUDAMED5031720FT12SJ5 EUDAMED5031720FT11058S EUDAMED5031720FT10008B EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMEDY06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDY060609 WRIST (FOREARM) ORTHOSES EUDAMEDY060615 ELBOW ORTHOSES EUDAMEDY060612 WRIST-HAND ORTHOSES EUDAMEDY061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMEDY060399 SPINE ORTHOSES - OTHER EUDAMEDY060606 HAND ORTHOSES EUDAMEDY061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMEDY061280 LOWER LIMB ORTHOSES - ACCESSORIES EUDAMEDY061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDEUDAMED
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
Fortuna by Fortuna Healthcare Limited — 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 | 5031720FT15HHQ | Class I | Active |
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Manufacturer
- Manufacturer
- Fortuna Healthcare Limited
- EUDAMED SRN
- UK-MF-000048072
- Authorised Representative
- Fortuna Healthcare (Ireland) Limited IE-AR-000044547
Sources (51)
- EUDAMED 2dbb7b1b-a63a-4dc8-96fb-c4169d204755 61 fields · synced Oct 7, 2026
- EUDAMED 7aa8697c-5ef6-4356-9662-08e6ece8ace9 61 fields · synced May 17, 2026
- EUDAMED a72ba22a-232b-4d69-92cc-8c6cd3321232 61 fields · synced May 17, 2026
- EUDAMED 60abd448-15af-4040-8ef0-74bffe074395 61 fields · synced May 17, 2026
- EUDAMED 0c88c786-9ead-4ce0-80e1-4182db582a57 61 fields · synced May 17, 2026
- EUDAMED 495ca50f-a6f9-48e2-acc2-61fc08ee6530 61 fields · synced May 17, 2026
- EUDAMED 00da42c6-4a19-4cd9-a05f-2df9b7410296 61 fields · synced May 18, 2026
- EUDAMED 2a1874e2-b819-4334-9328-840d1d9ac815 61 fields · synced May 18, 2026
- EUDAMED e3b800c8-3dcf-4401-9517-eab472bb8fd7 61 fields · synced May 19, 2026
- EUDAMED ef17e793-8469-45a3-a09c-f6aaa6640362 61 fields · synced Jun 18, 2026
- EUDAMED 797a0561-7256-43b6-845e-6fe81dfcc30c 61 fields · synced Jun 20, 2026
- EUDAMED 1c87e120-3b45-4954-b761-f3f07f0da14b 61 fields · synced Jun 20, 2026
- EUDAMED 99720f1c-7188-44a2-afab-2a8bcb2fa863 61 fields · synced Jun 20, 2026
- EUDAMED 26c9a2a8-6ff3-4273-b54e-346f7b99fee7 61 fields · synced Jun 20, 2026
- EUDAMED 25e6c3de-f51d-43a1-a47a-62e7c9113f91 61 fields · synced Jul 8, 2026
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- EUDAMED b19f0248-77cc-47cf-b33a-de649d8cadad 61 fields · synced Jul 9, 2026
- EUDAMED 3188415d-d023-4d16-a645-7df5c9b0fc84 61 fields · synced Jul 9, 2026
- EUDAMED 27545505-14e7-4464-8be8-9ea059d6e2db 61 fields · synced Jul 9, 2026
- EUDAMED 6b2d9240-4277-4879-a725-e44eee71ca83 61 fields · synced Jul 9, 2026
- EUDAMED 1ebec7bd-34aa-46f3-9d67-1488e5b8a5be 61 fields · synced Jul 10, 2026
- EUDAMED 7fdf91c8-69ea-4dbd-9b8c-046d77b72833 61 fields · synced Jul 10, 2026
- EUDAMED af824e4b-79aa-4137-9593-f4edab0d29ee 61 fields · synced Jul 10, 2026
- EUDAMED 3bec4ecc-c5ae-452a-bca8-a981fe1c3e9a 61 fields · synced Jul 10, 2026
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- EUDAMED 75315387-8808-4281-a59b-93abf939622c 61 fields · synced Jul 10, 2026
- EUDAMED 012280c2-beaa-4ca3-96a9-42208ba8ed04 61 fields · synced Jul 10, 2026
- EUDAMED 8df03373-0e70-4d48-b465-e369bd85d37d 61 fields · synced Jul 10, 2026
- EUDAMED 7abe5b1b-6377-4ddd-9795-f0bf7fac6e9c 61 fields · synced Jul 11, 2026
- EUDAMED ac49e44c-cf22-4d67-9d3a-845d48b1c9ab 61 fields · synced Jul 12, 2026
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- EUDAMED 2dd4e032-ea23-41d9-a673-3bc8eca77a9a 61 fields · synced Jul 13, 2026
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- EUDAMED efd46f7f-26d9-4f24-8a79-aa56a2866552 61 fields · synced Jul 15, 2026
- EUDAMED 76dbda8a-ae4b-4948-9363-8f9883a5f62c 61 fields · synced Jul 15, 2026
- EUDAMED e372ad7e-4796-456b-b22c-443365117450 61 fields · synced Jul 15, 2026
- EUDAMED 0531504b-d3b8-41ba-8984-39b45da4ecd1 61 fields · synced Jul 16, 2026
- EUDAMED 11b54600-4862-48af-ace5-5b9e049bf46c 61 fields · synced Jul 16, 2026
- EUDAMED 9c680912-61d4-439c-b8b2-c74d5aae678c 61 fields · synced Jul 16, 2026
- EUDAMED cae14d5d-ab40-49cf-9214-53cfebc9e331 61 fields · synced Jul 18, 2026
- EUDAMED 26978251-ec8b-4fcc-8fb2-2a1afda8cfe5 61 fields · synced Jul 18, 2026
- EUDAMED 6f23fdc1-4197-4498-b201-6903443a756b 61 fields · synced Jul 18, 2026
- EUDAMED a33176c2-0893-472b-bad4-080d1bc6400d 61 fields · synced Jul 20, 2026
- EUDAMED 905e8ed0-8ded-4e27-babe-f6c8d0f184e5 61 fields · synced Jul 20, 2026
- EUDAMED 544ef124-134c-4a90-84f7-48b0a1648694 61 fields · synced Jul 22, 2026
- EUDAMED 246dd796-d409-45c4-abb3-943f38b87a8a 61 fields · synced Jul 23, 2026
- EUDAMED f43ca3ef-0c5b-413f-9e14-ea1a4fa2d850 61 fields · synced Jul 25, 2026
- EUDAMED c6d311fa-3a93-4ca3-b170-78dfe44150b5 61 fields · synced Jul 25, 2026
- EUDAMED c0c5f8ec-027f-4753-ab96-e7d8e5dca4dd 61 fields · synced Jul 29, 2026
- EUDAMED 32ec1004-923e-4543-9989-f1009a1d4774 61 fields · synced Jul 29, 2026
- EUDAMED 6b0b03b0-6102-4a25-a23d-0cc29b53027c 61 fields · synced Jul 29, 2026