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HIKE M4 Orteza stawu kolanowego z zawiasami
EUDAMEDClass I (EU MDR)
Ref DRQI7K1LAX03PRef DRQI7K1LAX01PRef DRQI7K1LAX02PRef DRQI7K1LAX05P
Identity
- Device Name
- HIKE M4 Orteza stawu kolanowego z zawiasami EUDAMED
- Model / Reference
- DRQI7K1LAX03P EUDAMEDDRQI7K1LAX01P EUDAMEDDRQI7K1LAX02P EUDAMEDDRQI7K1LAX05P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901780451240 EUDAMED05901780451226 EUDAMED05901780451233 EUDAMED05901780451264 EUDAMED
- Basic UDI-DI
- 59017804DRQI7KN7 EUDAMED
- Direct Marketing DI
- 05901780451240 EUDAMED05901780451226 EUDAMED05901780451233 EUDAMED05901780451264 EUDAMED
- EMDN Code
- Y061209 KNEE 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
HIKE M4 Orteza stawu kolanowego z zawiasami by mdh sp. z o. 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 | 59017804DRQI7KN7 | Class I | Active |
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Manufacturer
- Manufacturer
- mdh sp. z o. o.
- EUDAMED SRN
- PL-MF-000011406
Sources (4)
- EUDAMED 683d3fee-72e8-4c1a-b356-f047925e7750 61 fields · synced Oct 6, 2026
- EUDAMED 45b5d1fc-fb5a-4887-8396-74320dac38f0 61 fields · synced May 18, 2026
- EUDAMED 26bbbc84-10fd-4b35-b9bf-f25474486750 61 fields · synced May 18, 2026
- EUDAMED 27c3335a-efa4-4ab3-bf77-97b0355572e3 61 fields · synced May 18, 2026