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simex

FDA UDI

Class II (US FDA UDI)

by Simex Medizintechnik GmbH

Identity

Trade Name
simex FDA UDI
Generic Name
Multi-purpose low-vacuum suction system FDA UDI
Device Name
SIMEX cuff M suction FDA UDI
Model / Reference
SIMEX cuff M FDA UDI
Description
SIMEX cuff M suction FDA UDI

Identifiers

Catalog Number
100678-3 FDA UDI
Primary DI / UDI-DI
04052262385957 FDA UDI
510(k) Number
K141255 FDA UDI
FDA Product Code
BTA FDA UDI
GMDN Term
Multi-purpose low-vacuum suction system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4780 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-purpose low-vacuum suction system

simex by Simex Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose low-vacuum suction system.

Cleared under the same submission

K141255 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Simex Medizintechnik GmbH

Sources (1)

  • FDA UDI 7d48de60-6832-4f78-8bfc-d28e09af6f33 37 fields · synced Jun 1, 2026