Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012913237

FEI Number

3012913237

Entity Name

CryoIQ global AB

City/State/Country

Onsala Halland, SE

Establishment Address

Apelrodsvagen 1, Onsala Halland 43932, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CryoIQ global AB (Owner Number: 10056378)

Owner / Operator Contact Address

Apelrodsvagen 1, Onsala, SE-NOTA 43932, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172049

PMA Number

N/A

All Registered Proprietary Names

CryoIQ MULTI LINE, CryoIQ Derm, CryoIQ PRO, CryoIQ EquiMed CryoIQ PRO A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2017-12-04

Official Correspondent

Stefan Skafte

US Agent Details

Cherita James Business: Pro Pharma Group Email: cherita.james@propharmagroup.com Phone: (347) 9540624

Related Public Records

Same Entity

CryoIQ global AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K190651	Erbe Elektromedizin GmbH	ERBECRYO 2 Cryosurgical Unit; ERBECRYO 2 1-pedal footswitch, Extension cable f. ERBECRYO 2 footswitch; Flexible Cryoprobe; ERBECRYO 2 Cart, VIO-Cart, Wire basket; Connecting hoses, switching valves, adapter	2020-01-07
K760953	Spembly Medical , Ltd.	DEEP FREEZE SYSTEM (DFS-30)	1976-11-16

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3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012913237. Last updated year: 2026. Please use registration number 3012913237 when referencing this establishment in official correspondence.