Identity
- Device Name
- Kelio įtvarinė sistema EUDAMED
- Model / Reference
- SKA562 EUDAMED8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04779052760700 EUDAMED
- Basic UDI-DI
- 477905276SKA562KJ EUDAMED
- Direct Marketing DI
- 04779052760700 EUDAMED
- EMDN Code
- Y061209 KNEE ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Lithuania 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
Kelio įtvarinė sistema by UAB Pirmas žingsnis — 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 | 477905276SKA562KJ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- UAB Pirmas žingsnis
- EUDAMED SRN
- LT-MF-000004764
Sources (1)
- EUDAMED 95a14cc8-2ec1-4bae-9b79-c4df75315f28 61 fields · synced Jun 19, 2026