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Gauze sponges 12x25cm, 16ply (CE)
EUDAMEDClass I (EU MDR)
Ref G12/25
by PANEP s.r.o.
Identity
- Trade Name
- Gauze sponges 12x25cm, 16ply (CE) EUDAMED
- Device Name
- PANEP BASIC ABSORPCE – Kompres z gázy EUDAMED
- Model / Reference
- G12/25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08592323005906 EUDAMED
- Basic UDI-DI
- 8592323GAZAKOMPRESNS2V EUDAMED
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Gauze sponges 12x25cm, 16ply (CE) by PANEP s.r.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 | 8592323GAZAKOMPRESNS2V | Class I | Active |
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Manufacturer
- Manufacturer
- PANEP s.r.o.
- EUDAMED SRN
- CZ-MF-000033142
Sources (1)
- EUDAMED 945b1586-13d9-4511-b274-f89251174fde 61 fields · synced Jul 28, 2026