Identity
- Trade Name
- System szynowy ISA EUDAMED
- Device Name
- Systemy szynowe ISA EUDAMED
- Model / Reference
- ISA EUDAMEDMD-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904126060984 EUDAMED
- Basic UDI-DI
- 5904126-ISA/JS EUDAMED
- Direct Marketing DI
- 05904126060984 EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER 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
System szynowy ISA by Zakład Techniki Medycznej "Tech-Med" 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 | 5904126-ISA/JS | Class I | Active |
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Manufacturer
- Manufacturer
- Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.
- EUDAMED SRN
- PL-MF-000009262
Sources (1)
- EUDAMED 03cbd400-eca7-46ae-b3f9-9030792bde78 61 fields · synced Oct 6, 2026