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Protek
EUDAMEDClass I (EU MDR)
Ref 20090Ref 20106Ref 22421Ref 21127Ref 21103Ref 21950
Identity
- Trade Name
- Protek EUDAMED
- Device Name
- Elasticated Ankle Support Extra Small EUDAMEDNeoprene Shoulder Support EUDAMEDTennis Elbow Support EUDAMEDNeoprene Thumb Brace EUDAMEDPosture Support EUDAMED
- Model / Reference
- 20090 EUDAMED20106 EUDAMED22421 EUDAMED21127 EUDAMED21103 EUDAMED21950 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060483320090 EUDAMED05060483320106 EUDAMED05060483322421 EUDAMED05060483321127 EUDAMED05060483321103 EUDAMED05060483321950 EUDAMED
- Basic UDI-DI
- 50604833TF201AR EUDAMED50604833TF204AX EUDAMED50604833TF211B69 EUDAMED50604833TF211A67 EUDAMED50604833TF219B6Z EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMEDM030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMEDY060624 SHOULDER-ELBOW ORTHOSES EUDAMEDM03050202 SYNTHETIC CAST BANDAGES AND SPLINTS EUDAMEDY060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDIreland 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: Ankle/foot orthosis
Protek by Lightwing Marketing Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ankle/foot orthosis.
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- ALIMED ANKLE BRACE ALL AIR TUBE — AliMed, LLC · Class I
- Ankle support with 2 straps - Neoprene - onesize — ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. · Class I
- Rebound® Air Walker LT — Össur Iceland ehf. · Class I
- Strp Blank Insert Only, SA, A/B Size, 3in Free Mot — Becker Orthopedic Appliance Company · Class I
- STABIBOOT 3D — GROUPE SOBER SAS · Class I
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 | 50604833TF201AR | Class I | Active |
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Manufacturer
- Manufacturer
- Lightwing Marketing Limited
- EUDAMED SRN
- UK-MF-000046146
- Authorised Representative
- Patient Guard Europe UG DE-AR-000007523
Sources (6)
- EUDAMED 88366a4a-9bde-4454-8acf-f9d86c4c0f70 61 fields · synced Jul 30, 2026
- EUDAMED 835167b4-1f6e-4121-8849-eb8b55103a97 61 fields · synced May 17, 2026
- EUDAMED ec74a632-9b7d-429f-858d-10a3d94a605f 61 fields · synced Jul 15, 2026
- EUDAMED fadbfe80-e8b0-4306-ba45-156e854ef4aa 61 fields · synced Jul 19, 2026
- EUDAMED d8bd1d56-efb6-4586-b3f3-2ebb7f95db60 61 fields · synced Jul 21, 2026
- EUDAMED 82247d20-f003-4d8b-96c4-7cc631790134 61 fields · synced Jul 30, 2026