Identity
- Trade Name
- ViVi® TOGA PREMIUM M-L EUDAMEDViVi TOGA Premium Size M-L FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- ViVi® GOWNS 82XXX EUDAMED
- Model / Reference
- 82221V EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 82221V FDA UDI
- Primary DI / UDI-DI
- 09009607832213 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 M-L 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 | 9009607GOWNS82XXXDJ | 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 (2)
- EUDAMED d999ed37-4eab-4027-9352-68bfe9f7f934 61 fields · synced Jun 19, 2026
- FDA UDI aa91aebe-cdae-4a83-8930-6b734b9f401f 34 fields · synced May 30, 2026