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ALPHAtex
EUDAMEDClass I (EU MDR)
Ref AT-AC
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- ALPHAtex EUDAMED
- Device Name
- covers for medical equipment EUDAMED
- Model / Reference
- AT-AC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996823956 EUDAMED
- Basic UDI-DI
- 59079968T030101-NNU EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
ALPHAtex by ZARYS International Spółka z ograniczoną odpowiedzialnością — 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 | 59079968T030101-NNU | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED e1370bd3-9e15-4547-b808-d84678a04d64 61 fields · synced Oct 8, 2026