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PM Excellence SEQUR 100

FDA UDI

Class II (US FDA UDI)

by Pm Excellence Llc Doo Beograd

Identity

Trade Name
PM Excellence SEQUR 100 FDA UDI
Generic Name
Surgical/medical face mask, antimicrobial, single-use FDA UDI
Device Name
PM Excellence SEQUR 100 is a flat pleated, 3-layer surgical face mask with non-latex elastic ear loops and malleable nose wire piece. Product Characteristics: • Three layers of breathable non-woven polypropylene fabric • Integrated shapeable nose wire for better fit • Non latex elastic ear loops for greater comfort • Non-cytotoxic, non-irritating and non-sensitizing • Single use, disposable, non-sterile • Provides full coverage, starting from the malleable component of the nose piece at the top all the way to the snug, yet comfortable fit under the chin. FDA UDI
Model / Reference
100 FDA UDI
Description
PM Excellence SEQUR 100 is a flat pleated, 3-layer surgical face mask with non-latex elastic ear loops and malleable nose wire piece. Product Characteristics: • Three layers of breathable non-woven polypropylene fabric • Integrated shapeable nose wire for better fit • Non latex elastic ear loops for greater comfort • Non-cytotoxic, non-irritating and non-sensitizing • Single use, disposable, non-sterile • Provides full coverage, starting from the malleable component of the nose piece at the top all the way to the snug, yet comfortable fit under the chin. FDA UDI

Identifiers

Primary DI / UDI-DI
10850037258083 FDA UDI
510(k) Number
K220520 FDA UDI
FDA Product Code
FXX FDA UDI
GMDN Term
Surgical/medical face mask, antimicrobial, single-use 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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: Surgical/medical face mask, antimicrobial, single-use

PM Excellence SEQUR 100 by Pm Excellence Llc Doo Beograd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, antimicrobial, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pm Excellence Llc Doo Beograd

Sources (1)

  • FDA UDI e7884855-4fc9-4121-a622-7ba2da27043e 34 fields · synced Jun 8, 2026