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Orteza na ramię i bark typu Dessault MEK 4005 XL
EUDAMEDClass I (EU MDR)
Ref 4005-xlModel MEK 4005
Identity
- Trade Name
- Orteza na ramię i bark typu Dessault MEK 4005 XL EUDAMED
- Device Name
- Orteza na ramię i bark typu Dessault EUDAMED
- Model / Reference
- MEK 4005 EUDAMED4005-xl EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904647710641 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 XL 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 c5161c2d-170c-4329-a2bd-5ad1c65cde5a 61 fields · synced Oct 6, 2026