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Hapla
EUDAMEDClass I (EU MDR)
Ref TOF111Ref TOF121Ref FEL120Ref FEL104Ref FLE970BRef HAP300Ref SWA104BRef CHI312Ref FEL160Ref FEL142Ref BAS010Model Orthotics Ref SWA104Ref FLE940Ref FEL115Ref FEL120BRef FEL152BRef NUP100Ref FEL140Ref FLE950Ref TOF700Ref FEL146Ref FEL128Ref FEL144Ref WAV010Ref SWA100BRef BAS008Ref BAS009Ref POR100Ref CHI314Ref HAP312Ref FLE950FRef HAP301Ref BAS006Ref BAS012Ref CHI316Ref FEL132Ref BAS013Ref FLE244BRef NUP104BRef PEF500Ref CHG204Ref CHG500Ref FEL108BRef FOA100BRef FLE240BRef CHG325
Identity
- Trade Name
- Hapla EUDAMED
- Device Name
- Adhesive & Non-Adhesive Paddings & Strappings EUDAMEDOrthotics EUDAMEDProtective Gels EUDAMED
- Model / Reference
- TOF111 EUDAMEDTOF121 EUDAMEDFEL120 EUDAMEDFEL104 EUDAMEDFLE970B EUDAMEDHAP300 EUDAMEDSWA104B EUDAMEDCHI312 EUDAMEDFEL160 EUDAMEDFEL142 EUDAMEDOrthotics EUDAMEDBAS010 EUDAMEDSWA104 EUDAMEDFLE940 EUDAMEDFEL115 EUDAMEDFEL120B EUDAMEDFEL152B EUDAMEDNUP100 EUDAMEDFEL140 EUDAMEDFLE950 EUDAMEDTOF700 EUDAMEDFEL146 EUDAMEDFEL128 EUDAMEDFEL144 EUDAMEDWAV010 EUDAMEDSWA100B EUDAMEDBAS008 EUDAMEDBAS009 EUDAMEDPOR100 EUDAMEDCHI314 EUDAMEDHAP312 EUDAMEDFLE950F EUDAMEDHAP301 EUDAMEDBAS006 EUDAMEDBAS012 EUDAMEDCHI316 EUDAMEDFEL132 EUDAMEDBAS013 EUDAMEDFLE244B EUDAMEDNUP104B EUDAMEDPEF500 EUDAMEDCHG204 EUDAMEDCHG500 EUDAMEDFEL108B EUDAMEDFOA100B EUDAMEDFLE240B EUDAMEDCHG325 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05012654205514 EUDAMED05012654205538 EUDAMED50126542043956 EUDAMED50126542086458 EUDAMED50126542077784 EUDAMED05012654207433 EUDAMED50126542035586 EUDAMED50126542076862 EUDAMED50126542045004 EUDAMED50126542044496 EUDAMED50126542040740 EUDAMED50126542054778 EUDAMED50126542046308 EUDAMED50126542043888 EUDAMED50126542000072 EUDAMED50126542000386 EUDAMED50126542048456 EUDAMED50126542044328 EUDAMED50126542046544 EUDAMED05012654207501 EUDAMED50126542044632 EUDAMED50126542044182 EUDAMED50126542044564 EUDAMED50126542024078 EUDAMED50126542000768 EUDAMED50126542040504 EUDAMED50126542040672 EUDAMED50126542007316 EUDAMED50126542076930 EUDAMED05012654207457 EUDAMED50126542046476 EUDAMED05012654207440 EUDAMED50126542040368 EUDAMED50126542040986 EUDAMED50126542077098 EUDAMED50126542044250 EUDAMED50126542041044 EUDAMED50126542043642 EUDAMED50126542087752 EUDAMED50126542088056 EUDAMED50126542083792 EUDAMED50126542087066 EUDAMED50126542076558 EUDAMED50126542087202 EUDAMED50126542089282 EUDAMED50126542007798 EUDAMED50126542076244 EUDAMED
- Basic UDI-DI
- 5012654PAD100C4 EUDAMED5012654ORT100M2 EUDAMED5012654GEL100BK EUDAMED
- EMDN Code
- M03030203 FOAM PADS EUDAMEDM010203 PADDING FELT EUDAMEDM040799 SPECIAL PADS - OTHER EUDAMEDM03030103 TUBULAR NET BANDAGES EUDAMEDH900299 TAPES, MEDICAL/SURGICAL - OTHER EUDAMEDY061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDNorthern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Hapla by Cuxson Gerrard & Co. 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 | 5012654PAD100C4 | Class I | Active |
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Manufacturer
- Manufacturer
- Cuxson Gerrard & Co. Ltd
- EUDAMED SRN
- GB-MF-000004499
- Authorised Representative
- Cuxson Gerrard Healthcare Ltd IE-AR-000003838
Sources (47)
- EUDAMED 070a0520-0f54-45e9-a9e5-09ffeba3ae1c 61 fields · synced Oct 5, 2026
- EUDAMED 9049319b-4c93-495c-b667-816302c1561c 61 fields · synced May 16, 2026
- EUDAMED 1385e1ed-6448-475c-8f94-fa83bda5e476 61 fields · synced May 16, 2026
- EUDAMED 1ea581ca-ae63-40df-9ccd-c57022dd02cf 61 fields · synced May 16, 2026
- EUDAMED b763aa86-5683-4599-8635-f18242089a06 61 fields · synced May 16, 2026
- EUDAMED 81b4c607-e56c-4f1b-a998-859411b65ae2 61 fields · synced May 16, 2026
- EUDAMED 42562435-c9aa-4f07-b683-d8cdff0bfd04 61 fields · synced May 16, 2026
- EUDAMED 818b8ea8-4327-4615-8d3e-7def28825c42 61 fields · synced May 17, 2026
- EUDAMED 8b89a751-7f57-49f2-b5c4-37be51fa9a8e 61 fields · synced May 17, 2026
- EUDAMED 94197eb4-7bdd-4e84-a648-c477d242eb88 61 fields · synced May 17, 2026
- EUDAMED 8272913c-41ab-49e6-ab7d-8f25d61dba16 61 fields · synced May 17, 2026
- EUDAMED 5d53b85d-5875-4b15-9f33-efc91f5d148d 61 fields · synced May 17, 2026
- EUDAMED ef7209fe-739a-4678-845f-e72edf69b56e 61 fields · synced May 17, 2026
- EUDAMED 83d1c71c-569a-43e5-95fd-3bccbc40c131 61 fields · synced May 17, 2026
- EUDAMED ad88b525-3093-4dc4-af44-0980da8384d4 61 fields · synced May 17, 2026
- EUDAMED 01f93f55-3193-4d2a-8ab4-c94a6ae5ac25 61 fields · synced May 17, 2026
- EUDAMED 33cd9a9b-b184-4f8f-8416-c71aaf3475bd 61 fields · synced May 17, 2026
- EUDAMED d44d28f1-02b6-4568-b480-530c737eebe1 61 fields · synced May 17, 2026
- EUDAMED 074a56c8-2918-443a-9580-fb87fa8a046c 61 fields · synced May 17, 2026
- EUDAMED 7edafd25-5873-406a-a9d4-93797ff25ea0 61 fields · synced May 17, 2026
- EUDAMED 6bc45e09-461e-4d7d-90a4-dd083f541601 61 fields · synced May 18, 2026
- EUDAMED 154890b4-4c2f-449b-9782-fda7ba234a07 61 fields · synced May 18, 2026
- EUDAMED 49eafcf4-117f-4297-a82d-a8e12e5cf2cb 61 fields · synced May 18, 2026
- EUDAMED 1318a624-ad9c-4586-8e1c-6939f2763706 61 fields · synced May 18, 2026
- EUDAMED cd79dde3-94a0-4b74-8ce7-2cf6c10fe9fd 61 fields · synced May 18, 2026
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- EUDAMED b5689382-dab8-444a-8ce5-f1deffd0f472 61 fields · synced May 18, 2026
- EUDAMED 2f27eadf-81b9-44b2-b386-6829f6e9c3ea 61 fields · synced May 18, 2026
- EUDAMED 58f863e6-4b2b-49cd-9b14-057d5f0b5181 61 fields · synced May 18, 2026
- EUDAMED cdfad027-59f5-4a99-8f62-adad6ff6a127 61 fields · synced May 18, 2026
- EUDAMED 1a37ab49-d679-490b-b099-b88f31804c65 61 fields · synced May 18, 2026
- EUDAMED 1002bd47-8490-4d80-a79c-401f4dc51767 61 fields · synced May 18, 2026
- EUDAMED e766f872-09e6-4070-9ce8-c540abffece1 61 fields · synced May 19, 2026
- EUDAMED a6a477b2-e7cc-4ce0-8a65-8e428b064beb 61 fields · synced May 19, 2026
- EUDAMED 3b5fc720-1587-4a21-b016-f6bbbe704ec4 61 fields · synced May 19, 2026
- EUDAMED f545d146-9208-4c16-841d-d851e4811bd0 61 fields · synced May 19, 2026
- EUDAMED 8c0f04d2-c1bf-464c-901d-b3e459c1c40f 61 fields · synced May 19, 2026
- EUDAMED 0b142eab-af6d-49f9-b294-588ee0bf14d3 61 fields · synced May 19, 2026
- EUDAMED 0987d351-7578-430c-a774-8cb5bcd2f4c2 61 fields · synced Jul 9, 2026
- EUDAMED 882c8381-71e6-49a9-b739-f222a2034ed3 61 fields · synced Jul 9, 2026
- EUDAMED f3787baa-6be2-48c1-bdd1-8a2dc0ae32d9 61 fields · synced Jul 9, 2026
- EUDAMED 6cd3bb8f-d2a8-40f8-9428-1c8579a85bce 61 fields · synced Jul 9, 2026
- EUDAMED 0db3c436-4a1b-48f2-9428-d2de481ee5af 61 fields · synced Jul 9, 2026
- EUDAMED 42f6ec27-af3d-4f43-bc27-9605db0a6563 61 fields · synced Jul 11, 2026
- EUDAMED 9c76c172-75cf-4d90-9fb7-9a5276602d27 61 fields · synced Jul 14, 2026
- EUDAMED 508a8032-3a78-4fb4-b0ef-a0943a2984f8 61 fields · synced Jul 22, 2026
- EUDAMED 8df8a9c3-55d1-4a1f-b702-f1e9eb8965e4 61 fields · synced Sep 17, 2026