Identity
- Trade Name
- INTRA SHIELD PLUS EUDAMEDINTRA SHIELD EUDAMED
- Device Name
- I.V. Cannula Fixator (Dressing & Securement Devices) EUDAMED
- Model / Reference
- GS-3167 EUDAMEDGS-3045 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08907265316711 EUDAMED08907265316704 EUDAMED08907265304503 EUDAMED
- Basic UDI-DI
- 8907265H001ZL EUDAMED
- EMDN Code
- M04010202 POLYURETHANE FIXING DRESSINGS EUDAMEDM04010201 NON-WOVEN FIXING DRESSINGS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Intra Shield Plus by Romsons Group Private 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 | 8907265H001ZL | Class I | Active |
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Manufacturer
- Manufacturer
- Romsons Group Private Limited
- EUDAMED SRN
- IN-MF-000036506
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 205dbf93-e9ad-4cfc-8a9d-0d2d7e3059fd 61 fields · synced Jul 15, 2026
- EUDAMED adf3225e-675f-4b1d-92b3-64ad9f09de7a 61 fields · synced May 17, 2026
- EUDAMED 3a653cde-48c7-4522-bc8a-410b552b96c7 61 fields · synced May 18, 2026