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hygh-tec

FDA UDI

Class II (US FDA UDI)

by Advanced Medical Balloons GmbH

Identity

Trade Name
hygh-tec FDA UDI
Generic Name
Faecal incontinence collector, catheterization FDA UDI
Device Name
hygh-tec® bag stool collection bag | 5 pcs FDA UDI
Model / Reference
V01-10026-05 FDA UDI
Description
hygh-tec® bag stool collection bag | 5 pcs FDA UDI

Identifiers

Primary DI / UDI-DI
04260566430147 FDA UDI
510(k) Number
K221400 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Faecal incontinence collector, catheterization FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Category: Faecal incontinence collector, catheterization

hygh-tec by Advanced Medical Balloons GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal incontinence collector, catheterization.

Cleared under the same submission

K221400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Balloons GmbH

Sources (1)

  • FDA UDI 60cdbfc0-b368-4ff8-829a-49fb55c73389 36 fields · synced Jun 6, 2026