Identity
- Device Name
- Záves hornej končatiny Acrofix EUDAMED
- Model / Reference
- J39989 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08586022601200 EUDAMED
- Basic UDI-DI
- 858602260120021070AZ EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Záves hornej končatiny Acrofix 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 | 858602260120021070AZ | Class I | Active |
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Manufacturer
- Manufacturer
- Mirbachplus s.r.o.
- EUDAMED SRN
- SK-MF-000053396
Sources (1)
- EUDAMED 7f23553d-cd60-40ea-92a6-0c22b4a6f980 61 fields · synced Jul 15, 2026