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Sigma
EUDAMEDClass I (EU MDR)
Ref 17.501.203Model Alfa
by Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
Identity
- Trade Name
- Sigma EUDAMED
- Model / Reference
- Alfa EUDAMED17.501.203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507652241 EUDAMED
- Basic UDI-DI
- 590450765175012L2 EUDAMED
- Direct Marketing DI
- 05904507652241 EUDAMED
- EMDN Code
- Z120616 ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY 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
Sigma by Przedsiębiorstwo Handlowo-Usługowe "Technomex" 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 | 590450765175012L2 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000038261
Sources (1)
- EUDAMED 8c34ad75-0987-4b00-b813-444824c47902 61 fields · synced Jun 18, 2026