Identity
- Device Name
- body fluid solidification gel EUDAMED
- Model / Reference
- 9830-750 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055761601152 EUDAMED
- Basic UDI-DI
- 505576166294736 EUDAMED
- Unit of Use DI
- 05055761602876 EUDAMED
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES 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
body fluid solidification gel 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 | 505576166294736 | Class I | Active |
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Manufacturer
- Manufacturer
- Vacsax Limited
- EUDAMED SRN
- GB-MF-000003621
- Authorised Representative
- Fannin Ltd. IE-AR-000002249
Sources (1)
- EUDAMED b456532e-58a2-4eed-9fff-e31ff4ed6d71 61 fields · synced Jun 18, 2026