Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003364331

FEI Number

3003364331

Entity Name

HANS HEPP GMBH & CO. KG

City/State/Country

HAMBURG Lower Saxony, DE

Establishment Address

GEORGSWERDER DAMM 16, HAMBURG Lower Saxony D-20539, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HANS HEPP GMBH & CO. KG (Owner Number: 9027829)

Owner / Operator Contact Address

GEORGSWERDER DAMM 16, --, HAMBURG D-20539, DE-NOTA --, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable Gloves Size L 600mm x 800mm bandaging cloth A plaster assortment compress 8cm x 10cm first aid dressing M compress 6cm x 8cm first aid dressing K compress 10cm x 12cm first aid dressing G Patient Examination Gloves ca. 17,5cm x 9,5cm medical face mask first aid kit 100mm x 100mm wound compresses 96cm x 96cm x 136cm triangular bandages

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2023-07-31
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2023-07-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-07-11
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2023-07-11
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2007-11-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2023-07-11
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2008-10-25
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-07-11
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2023-07-11

Official Correspondent

No official correspondent registered.

US Agent Details

KEVIN WALLS Business: REGULATORY INSIGHT, INC. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

HANS HEPP GMBH & CO. KG

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
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003364331. Last updated year: 2026. Please use registration number 3003364331 when referencing this establishment in official correspondence.