Identity
- Trade Name
- Cervical collar, soft EUDAMED
- Device Name
- Kołnierz ortopedyczny, wielokrotnego użytku EUDAMED
- Model / Reference
- MEK 1001 EUDAMED1001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904647710009 EUDAMED
- Basic UDI-DI
- 59046477110015E EUDAMED
- EMDN Code
- Y060312 CERVICAL SPINE 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
Cervical collar, soft 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 | 59046477110015E | Class I | Active |
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Manufacturer
- Manufacturer
- MEK-ORTO Sp. z o.o.
- EUDAMED SRN
- PL-MF-000019251
Sources (1)
- EUDAMED 9c1eaa6f-b99b-40c2-9f2b-d1d6eb2133ae 61 fields · synced Jul 15, 2026