Identity
- Device Name
- Ortéza neoprénová lakťová bez popruhu Ľ / P EUDAMED
- Model / Reference
- J60509 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586022601422 EUDAMED
- Basic UDI-DI
- 858602260141501509ER EUDAMED
- EMDN Code
- Y060615 ELBOW ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovakia 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
Ortéza neoprénová lakťová bez popruhu Ľ / P by Mirbachplus s.r.o. — 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 | 858602260141501509ER | Class I | Active |
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Manufacturer
- Manufacturer
- Mirbachplus s.r.o.
- EUDAMED SRN
- SK-MF-000053396
Sources (1)
- EUDAMED 947a2382-01e2-4997-98ca-94ffcb419a90 61 fields · synced Oct 6, 2026