Identity
- Trade Name
- Gelsax Bacticlear EUDAMED
- Device Name
- 2000ml suction liner EUDAMED
- Model / Reference
- VAL-201 EUDAMEDEAL-211 EUDAMEDGAL-313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055761603477 EUDAMED05055761603132 EUDAMED
- Basic UDI-DI
- 50557616449422L EUDAMED
- EMDN Code
- A06030401 INTRAOPERATIVE SUCTION CONTAINERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Gelsax Bacticlear by Vacsax Limited — 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 | 50557616449422L | Class I | Active |
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Manufacturer
- Manufacturer
- Vacsax Limited
- EUDAMED SRN
- GB-MF-000003621
- Authorised Representative
- Fannin Ltd. IE-AR-000002249
Sources (2)
- EUDAMED ca39370c-8999-457f-b88d-6066f081e91a 61 fields · synced Jul 22, 2026
- EUDAMED c508fdd3-23d8-463e-a8b4-525aeedf1e41 61 fields · synced May 19, 2026