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Ametyst
EUDAMEDClass I (EU MDR)
Ref 13501301Model AMETYST
by Przedsiębiorstwo Handlowo-Usługowe "Technomex" Sp. z o.o.
Identity
- Trade Name
- AMETYST EUDAMED
- Model / Reference
- AMETYST EUDAMED13501301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05904507653224 EUDAMED
- Basic UDI-DI
- 590450765135013JQ 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
Ametyst 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 | 590450765135013JQ | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000038261
Sources (1)
- EUDAMED 4f246980-d5f9-4a8d-8e4e-93214bb18525 61 fields · synced Oct 6, 2026