Identity
- Trade Name
- 4Seal Senso EUDAMED
- Model / Reference
- BU00001 EUDAMEDM896338 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690977567986 EUDAMED
- Basic UDI-DI
- 5690967BU00001MT EUDAMED
- EMDN Code
- Y062415 TRANSFEMORAL PROSTHESES (FOR AMPUTATION ABOVE KNEE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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: Mechatronic external knee prosthesis
4Seal Senso by Össur Iceland ehf. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mechatronic external knee prosthesis.
- VGK-S — Orthomobility Ltd. · Class I
- NORD LINER TF CYLINDRICAL - TYPE 3.1 NF-53 — Nord Ability AB · Class I
- 5 Bar Knee Joint for AK with manual locking, Al — ST&G Corporation · Class I
- Symphony Cushion Liner for AK 32 — ST&G Corporation · Class I
- Socket adapter with adjustment core support (aluminium) — Elitex Prodexim SRL · Class I
- MERCURY EXT. KNEE PROSTHESIS 30mm SWING — BLATCHFORD PRODUCTS LIMITED · Class I
- Avior Accessories Kit (Rest of World) — BLATCHFORD PRODUCTS LIMITED · Class I
- Single-axis knee joint — Elitex Prodexim SRL · 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 | 5690967BU00001MT | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Össur Iceland ehf.
- EUDAMED SRN
- IS-MF-000000173
Sources (1)
- EUDAMED 46c26b76-b2ae-4b7c-ac09-a58966c582dd 61 fields · synced Jul 8, 2026