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ALPHAtex 2-layer surgical drape with central adhesive fenestration, sterile
EUDAMEDClass I (EU MDR)
Ref AT-NFFA-S 2
by ZARYS International Spółka z ograniczoną odpowiedzialnością
Identity
- Trade Name
- ALPHAtex 2-layer surgical drape with central adhesive fenestration, sterile EUDAMED
- Device Name
- surgical drapes EUDAMED
- Model / Reference
- AT-NFFA-S 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907996873173 EUDAMED
- Basic UDI-DI
- 59079968T0201QW EUDAMED
- EMDN Code
- T020102 SPECIALISTIC SURGERY DRAPES 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 2-layer surgical drape with central adhesive fenestration, sterile by ZARYS International Spółka z ograniczoną odpowiedzialnością — Class I — MDR…
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 | 59079968T0201QW | Class I | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000000410
Sources (1)
- EUDAMED 4cd50994-10f4-466f-bfbb-d1eb5f8ce8eb 61 fields · synced Oct 9, 2026