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: SUCTION WASTE COLLECTOR 1800ML FDA UDI
Model / Reference: HY-12036 FDA UDI
Description: SUCTION WASTE COLLECTOR 1800ML FDA UDI

Identifiers

Catalog Number: HY-12036 FDA UDI
Primary DI / UDI-DI: 03615140004343 FDA UDI
FDA Product Code: EBR FDA UDI
GMDN Term: Bowl/basin stand FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization 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.

One Degree Medical — ONE DEGREE MEDICAL HOLDINGS, LLC · Class I
Imperial Stailess Stell Pail — Imperial Surgical Ltd · Class I
Imperial Oval Stainless Steel Basin — Imperial Surgical Ltd · Class I
Imperial Stainless Steel Pail — Imperial Surgical Ltd · Class I
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
Imperial Stainless Steel Basin — Imperial Surgical Ltd · Class I
HYGITECH — HYGITECH · Class I
HYGITECH — HYGITECH · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Hygitech

Sources (1)

FDA UDI 67fb3087-ce08-4861-91b4-9d5ab44e9d1e 34 fields · synced May 30, 2026