Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013841116

FEI Number

3013841116

Entity Name

SOFTCOMPRESS

City/State/Country

Essen North Rhine-Westphalia, DE

Establishment Address

Kiekenberg 3, Essen North Rhine-Westphalia 45359, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Softcompress (Owner Number: 10055600)

Owner / Operator Contact Address

Kiekenberg 3, Essen, DE-NW 45359, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Juzo SoftCompress Short Stretch Bandage Juzo SoftCompress Rapidelast V - Gauze Bandage Juzo SoftCompress Bandage Liner, Sheet Juzo SoftCompress Bandage Liner, Roll Juzo SoftCompress Bandage Liner - Lower Leg Juzo SoftCompress Bandage Liner - Arm Juzo SoftCompress Breast Pad Juzo SoftCompress Hand Pad Juzo SoftCompress Malleo Pad Juzo SoftCompress Elbow Joint Pad Juzo SoftCompress Genital Pad Juzo SoftCompress Knee Joint Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2017-08-19
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2017-08-19
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	2017-08-19

Official Correspondent

Dennis Ptasik

US Agent Details

Petra Zorn Business: JULIUS ZORN, INC. Email: pzorn@juzousa.com Phone: (330) 9234999

Related Public Records

Same Entity

Softcompress

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013841116. Last updated year: 2026. Please use registration number 3013841116 when referencing this establishment in official correspondence.