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Opal
EUDAMEDClass I (EU MDR)
Ref 14501201Model OPAL
by Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
Identity
- Trade Name
- OPAL EUDAMED
- Model / Reference
- OPAL EUDAMED14501201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507651503 EUDAMED
- Basic UDI-DI
- 590450765145012JZ EUDAMED
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT 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
Opal 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 | 590450765145012JZ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000038261
Sources (1)
- EUDAMED 40a93d6c-fa49-4976-b85b-ff1042e32567 61 fields · synced Jun 19, 2026