Identity
- Trade Name
- ViVi® HOOD HFD EUDAMEDViVi® Hood EUDAMED
- Device Name
- ViVi® GOWNS 80XXX EUDAMED
- Model / Reference
- 80301 EUDAMED80200 EUDAMED80301V EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09009607803015 EUDAMED09009607802001 EUDAMED09009607813014 EUDAMED
- Basic UDI-DI
- 9009607GOWNS80XXXD4 EUDAMED
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
ViVi® HOOD HFD by Thi Total Healthcare Innovation Gmbh — 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 | 9009607GOWNS80XXXD4 | Class I | Active |
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Manufacturer
- Manufacturer
- THI Total Healthcare Innovation GmbH
- EUDAMED SRN
- AT-MF-000044495
Sources (3)
- EUDAMED 1f9fd866-7a6b-4723-b187-b41823f8c412 61 fields · synced Jul 25, 2026
- EUDAMED f7197726-bdba-43a7-a4d7-e210c9e204eb 61 fields · synced May 17, 2026
- EUDAMED ddca70c3-4726-4f8a-a619-c258ec65f7e7 61 fields · synced May 19, 2026