Identity
- Trade Name
- ViVi® HELMET²⁵ XL EUDAMED
- Device Name
- ViVi® HELMET²⁵ EUDAMED
- Model / Reference
- ViVi® HELMET²⁵ EUDAMED81100XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09009607811010 EUDAMED
- Basic UDI-DI
- 9009607HELMET81XXXHK EUDAMED
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
Classification
- Device Class
- Class I 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
Category: Surgical binoculars, reusable
ViVi® HELMET²⁵ XL by Thi Total Healthcare Innovation Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 9009607HELMET81XXXHK | Class I | Active |
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Manufacturer
- Manufacturer
- THI Total Healthcare Innovation GmbH
- EUDAMED SRN
- AT-MF-000044495
Sources (1)
- EUDAMED 1bc88fcb-8da9-4e4f-a446-506c0e749348 61 fields · synced Jun 18, 2026