Identity
- Trade Name
- Temblak siatkowy MEK 5002 XS EUDAMED
- Device Name
- Temblak MEK 5002 EUDAMED
- Model / Reference
- MEK 5002 EUDAMED5002-xs EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904647710900 EUDAMED
- Basic UDI-DI
- 59046477150026C 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
Temblak siatkowy MEK 5002 XS 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 | 59046477150026C | Class I | Active |
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Manufacturer
- Manufacturer
- MEK-ORTO Sp. z o.o.
- EUDAMED SRN
- PL-MF-000019251
Sources (1)
- EUDAMED 12a161c6-6285-4ef7-96f2-65d182f60879 61 fields · synced Jun 19, 2026