Identity
- Trade Name
- Spiroguard Re-usable EUDAMED
- Device Name
- Respiratory Filters - Various EUDAMED
- Model / Reference
- 2800/R1ZAUA001/0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060120954220 EUDAMED
- Basic UDI-DI
- 506012095Cat277 EUDAMED
- EMDN Code
- R049001 PULMONARY FUNCTION TEST FILTERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Spiroguard Re-usable by GVS Filter Technology UK Ltd — Class IIa — 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 | 506012095Cat277 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GVS Filter Technology UK Limited
- EUDAMED SRN
- UK-MF-000045036
- Authorised Representative
- GVS S.p.A. IT-AR-000028148
Sources (1)
- EUDAMED b0afb659-4574-4d32-be61-7ea36b25788b 61 fields · synced Jul 28, 2026