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Zeni Medical

FDA UDI

Class I (US FDA UDI)

by Focus Health Group

Identity

Trade Name
Zeni Medical FDA UDI
Generic Name
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Model / Reference
600660 FDA UDI

Identifiers

Primary DI / UDI-DI
00324357606600 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Zeni Medical by Focus Health Group — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Focus Health Group

Sources (1)

  • FDA UDI 666242e8-03fb-493d-9b0d-f2736502a254 32 fields · synced May 31, 2026