Identity
- Trade Name
- ViVi® PEEL-OFF HOOD EUDAMEDViVi PEEL-OFF HOOD FDA UDI
- Generic Name
- Surgical hood FDA UDI
- Device Name
- ViVi® GOWNS 80XXX EUDAMED
- Model / Reference
- 80500 EUDAMED80500V EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 80500V FDA UDI
- Primary DI / UDI-DI
- 09009607805002 EUDAMED09009607815001 EUDAMEDFDA UDI
- Basic UDI-DI
- 9009607GOWNS80XXXD4 EUDAMED
- FDA Product Code
- FXY FDA UDI
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
- GMDN Term
- Surgical hood FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
ViVi® PEEL-OFF HOOD by Thi Total Healthcare Innovation Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 9009607GOWNS80XXXD4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- THI Total Healthcare Innovation GmbH
- EUDAMED SRN
- AT-MF-000044495
Sources (3)
- EUDAMED 8541cf8e-7400-46cf-82b5-4dd405995a8c 61 fields · synced Jul 24, 2026
- EUDAMED 07e84d82-793c-4cf7-825e-3a6b2f3207e7 61 fields · synced May 16, 2026
- FDA UDI 52c24918-1d8d-40bd-84fb-e6c734e6efc9 34 fields · synced May 29, 2026