Identity
- Trade Name
- ViVi® TOGA PREMIUM XL-XXL EUDAMEDViVi TOGA Premium Size XL-XXL FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- ViVi® GOWNS 82XXX EUDAMED
- Model / Reference
- 82220V EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 82220V FDA UDI
- Primary DI / UDI-DI
- 09009607832206 EUDAMEDFDA UDI
- Basic UDI-DI
- 9009607GOWNS82XXXDJ EUDAMED
- FDA Product Code
- FYA FDA UDI
- EMDN Code
- T020401 STANDARD SURGICAL GOWNS EUDAMED
- GMDN Term
- Surgical gown, single-use 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® TOGA PREMIUM XL-XXL by Thi Total Healthcare Innovation Gmbh — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243522 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 9009607GOWNS82XXXDJ | Class I | Active |
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Manufacturer
- Manufacturer
- THI Total Healthcare Innovation GmbH
- EUDAMED SRN
- AT-MF-000044495
Sources (3)
- EUDAMED 80ff10c8-47a0-4904-8001-7b345e8ad23a 61 fields · synced Jul 15, 2026
- FDA UDI b0e98c8b-cec6-4636-8d4b-07f03a9ef68e 34 fields · synced May 30, 2026
- FDA 510(k) K243522 1 fields · synced May 18, 2026