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ALPHAtex Surgical gown STANDARD PLUS, with impermeable parts, sterile
EUDAMEDClass I (EU MDR)
Ref AT-SGSP-XL 1-CN
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- ALPHAtex Surgical gown STANDARD PLUS, with impermeable parts, sterile EUDAMED
- Device Name
- surgical gown EUDAMED
- Model / Reference
- AT-SGSP-XL 1-CN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996896790 EUDAMED
- Basic UDI-DI
- 59079968T020402HC EUDAMED
- EMDN Code
- T020402 REINFORCED SURGICAL GOWNS 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 Surgical gown STANDARD PLUS, with impermeable parts, sterile by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class I — MDR — listed…
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 | 59079968T020402HC | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED b209bd8b-4c6b-4a33-9d0a-74467c4260cb 61 fields · synced Oct 9, 2026