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Penguin RFA

FDA UDI

Class I (US FDA UDI)

by Integration Diagnostics Sweden AB

Identity

Trade Name
Penguin RFA FDA UDI
Generic Name
Multimeter FDA UDI
Model / Reference
Penguin RFA Instrument Kit Klockner White FDA UDI

Identifiers

Catalog Number
55002-KW FDA UDI
Primary DI / UDI-DI
07350096320135 FDA UDI
510(k) Number
K143445 FDA UDI
FDA Product Code
EKX FDA UDI
GMDN Term
Multimeter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 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: Multimeter

Penguin RFA by Integration Diagnostics Sweden AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multimeter.

Cleared under the same submission

K143445 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integration Diagnostics Sweden AB

Sources (1)

  • FDA UDI 257322a2-919f-4e21-b01e-a3dcbc7e7b2f 34 fields · synced May 30, 2026