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Hygitech

FDA UDI

Class I (US FDA UDI)

by Hygitech

Identity

Trade Name
HYGITECH FDA UDI
Generic Name
Bowl/basin stand FDA UDI
Device Name
The infusion stand is ideal for irrigation during implant surgery. Manual height adjustment: max 2 meters More info Total diameter: 30 mm Wheelbase: 52 cm Maximum load per hook: 6kg 2 year warranty Made in France FDA UDI
Model / Reference
HY-90070 FDA UDI
Description
The infusion stand is ideal for irrigation during implant surgery. Manual height adjustment: max 2 meters More info Total diameter: 30 mm Wheelbase: 52 cm Maximum load per hook: 6kg 2 year warranty Made in France FDA UDI

Identifiers

Catalog Number
HY-90070 FDA UDI
Primary DI / UDI-DI
03615140000086 FDA UDI
FDA Product Code
GFJ FDA UDI
GMDN Term
Bowl/basin stand FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Bowl/basin stand

Hygitech by Hygitech — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bowl/basin stand.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hygitech

Sources (1)

  • FDA UDI c74ba0ce-2b15-4df5-9e3c-f52374b2931f 34 fields · synced May 30, 2026