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ALPHAtex NS Surgical gown PREMIUM, non-sterile
EUDAMEDClass I (EU MDR)
Ref AT-NS-SGP-L 1E
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- ALPHAtex NS Surgical gown PREMIUM, non-sterile EUDAMED
- Device Name
- non-sterile surgical gowns EUDAMED
- Model / Reference
- AT-NS-SGP-L 1E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996843855 EUDAMED
- Basic UDI-DI
- 59079968T0204R4 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS 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
ALPHAtex NS Surgical gown PREMIUM, non-sterile by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed in EUDAMED
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 | 59079968T0204R4 | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 04ac5ec6-656d-4c5b-a58e-09cd957b2ee5 61 fields · synced Oct 9, 2026