Identity
- Trade Name
- Formfit® Tracker EUDAMED
- Model / Reference
- BU00019 EUDAMED719168 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05690967963132 EUDAMED
- Basic UDI-DI
- 5690967BU00019NE EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES 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
Formfit® Tracker by Össur Iceland ehf. — 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 | 5690967BU00019NE | 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 17bb55eb-d798-4185-9391-c70f2129ebc3 61 fields · synced Sep 17, 2026