Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015521867

FEI Number

3015521867

Entity Name

IEDERZ

City/State/Country

Groningen, NL

Establishment Address

Van der Hoopstraat 3, Groningen 9716 JK, NL

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

iederz (Owner Number: 10060588)

Owner / Operator Contact Address

Peizerweg 128, Groningen, NL-GR 9727 AN, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161294

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2019-05-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-05-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-05-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2019-05-29

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

iederz

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

Similar Registrations

Registration Number	Establishment Name	Location
3004753330	H&O EQUIPMENTS NV/Clinic6	Ghislenghien Hainaut, BE
3010140265	CSA Medical	Lexington, MA, US
3012697079	COOL RENEWAL, LLC	Nashville, TN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3010242262	KONINKLIJKE (ROYAL) UTERMOHLEN N.V.	Wolvega Fryslan, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015521867. Last updated year: 2026. Please use registration number 3015521867 when referencing this establishment in official correspondence.