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AeroFit Orteza stabilizująca staw skokowy
EUDAMEDClass I (EU MDR)
Ref DRQI7G1LAX02PRef DRQI7G1LAX03P
Identity
- Trade Name
- AeroFit Orteza stabilizująca staw skokowy EUDAMED
- Device Name
- AeroFit Orteza stabilizująca staw skokowy EUDAMED
- Model / Reference
- DRQI7G1LAX02P EUDAMEDDRQI7G1LAX03P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901780450977 EUDAMED05901780450984 EUDAMED
- Basic UDI-DI
- 59017804DRQI7GMX EUDAMED
- Direct Marketing DI
- 05901780450977 EUDAMED05901780450984 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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: Ankle/foot orthosis
AeroFit Orteza stabilizująca staw skokowy by mdh sp. z o. o. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 59017804DRQI7GMX | Class I | Active |
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Manufacturer
- Manufacturer
- mdh sp. z o. o.
- EUDAMED SRN
- PL-MF-000011406
Sources (2)
- EUDAMED 3a94d159-8122-497f-b6d6-88ae141c041e 61 fields · synced Oct 1, 2026
- EUDAMED ff97b89e-5763-4579-ae98-77f31f14530d 61 fields · synced May 18, 2026