Identity
- Trade Name
- HYGITECH FDA UDI
- Generic Name
- Lens loop, reusable FDA UDI
- Device Name
- The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures. Characteristics : • A Velcro strap allows comfortable adjustment of the loupe around the head • The loupe can be moved up and down to better align the eyes with the magnified area • The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object • Available in two magnifications, x2.5 or x3.5 Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use. Light - Weighing only 70g, the HYGITECH loupe is remarkably light. Practical - Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field FDA UDI
- Model / Reference
- HY-07106 FDA UDI
- Description
- The HYGITECH loupe is an optical instrument developed to facilitate visualisation of specific objects or areas. It was conceived for all precise work as well as helping improve performance of dental surgeons during technical procedures. Characteristics : • A Velcro strap allows comfortable adjustment of the loupe around the head • The loupe can be moved up and down to better align the eyes with the magnified area • The unbreakable lenses protect the eyes, help your eyes adjust quickly and comfortably and give the exact hue of the magnified object • Available in two magnifications, x2.5 or x3.5 Ergonomic - Perfectly adjustable around the head, the loupe’s ergonomics offer true comfort and incomparable ease of use. Light - Weighing only 70g, the HYGITECH loupe is remarkably light. Practical - Allowing assistance during technical procedures, the loupe helps give the dental surgeon a better approach to the surgical field FDA UDI
Identifiers
- Catalog Number
- HY-07106 FDA UDI
- Primary DI / UDI-DI
- 03615140000192 FDA UDI
- 510(k) Number
- K173062 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Lens loop, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Lens loop, reusable
Hygitech by Hygitech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hygitech
Sources (1)
- FDA UDI db9b831a-ee8d-477a-8f34-345c703c9556 35 fields · synced Jun 1, 2026