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ViVi® HELMET
EUDAMEDFDA UDIClass I (EU MDR)
Ref 80100 Rev-S4Model ViVi® HELMETRef 80130
Identity
- Trade Name
- ViVi® HELMET EUDAMEDViVi® HELMET HPL EUDAMEDViVi Helmet HPL FDA UDI
- Generic Name
- Surgical helmet system FDA UDI
- Device Name
- ViVi® HELMET EUDAMED
- Model / Reference
- ViVi® HELMET EUDAMED80100 Rev-S4 EUDAMED80130 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 80130 FDA UDI
- Primary DI / UDI-DI
- 09009607801042 EUDAMED09009607801301 EUDAMEDFDA UDI
- Basic UDI-DI
- 9009607HELMET80XXXHC EUDAMED
- FDA Product Code
- FXY FDA UDI
- EMDN Code
- L0316 HELMETS AND BINOCULAR GLASSES FOR SURGEONS EUDAMED
- GMDN Term
- Surgical helmet system 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical binoculars, reusable
ViVi® HELMET by Thi Total Healthcare Innovation Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical binoculars, reusable.
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- Surgical Telescope — Xenosys Co., Ltd. · Class I
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 | 9009607HELMET80XXXHC | 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 f42f925b-1731-45fe-b1f0-307f89b30e33 61 fields · synced Aug 1, 2026
- EUDAMED 2068b723-02f4-45b1-bbca-a2687e9a485f 61 fields · synced May 18, 2026
- FDA UDI 73e25561-7a20-4180-9fa7-160da0c2abbd 34 fields · synced May 30, 2026