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Orteza na ramię i bark typu Dessault MEK 4005 XXL
EUDAMEDClass I (EU MDR)
Ref 4005-xxlModel MEK 4005
Identity
- Trade Name
- Orteza na ramię i bark typu Dessault MEK 4005 XXL EUDAMED
- Device Name
- Orteza na ramię i bark typu Dessault EUDAMED
- Model / Reference
- MEK 4005 EUDAMED4005-xxl EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904647710658 EUDAMED
- Basic UDI-DI
- 59046477140056B EUDAMED
- EMDN Code
- Y060621 SHOULDER 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
Orteza na ramię i bark typu Dessault MEK 4005 XXL by MEK-ORTO 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 | 59046477140056B | Class I | Active |
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Manufacturer
- Manufacturer
- MEK-ORTO Sp. z o.o.
- EUDAMED SRN
- PL-MF-000019251
Sources (1)
- EUDAMED e4b55048-9a50-4c54-ba0c-c18efe0be887 61 fields · synced Oct 7, 2026