ADVANCED MEDICAL BALLOONS GMBH

FDA Device Registration & Listing · Waghaeusel Baden-Wurttemberg, DE · Registration 3015237508

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015237508
FEI Number
3015237508
Entity Name
ADVANCED MEDICAL BALLOONS GMBH
City/State/Country
Waghaeusel Baden-Wurttemberg, DE
Establishment Address
Bruchsaler Str. 22, Waghaeusel Baden-Wurttemberg 68753, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SAGE PRODUCTS LLC (Owner Number: 9914017)
Owner / Operator Contact Address
3909 THREE OAKS RD., --, Cary, IL 60013, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

hygh-tec bag hygh-tec drainage

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2025-12-16

Official Correspondent

Steven Merrill

US Agent Details

Steven Merrill Business: Sage Products LLC Email: steve.merrill@stryker.com Phone: (224) 3437214

Related Public Records

Same Entity

SAGE PRODUCTS LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1419181 SAGE PRODUCTS LLC CARY, IL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K900590 Biosearch Medical Products, Inc. BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING 1990-08-02
K102548 Footprint Medical, Inc. FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE 2010-11-26
K955248 United States Endoscopy Group, Inc. U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT 1996-05-21
K872921 Medical Support, Inc. MSS ENTERAL DELIVERY SET 1987-12-03
K180622 Covidien Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port 2018-10-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015237508. Last updated year: 2026. Please use registration number 3015237508 when referencing this establishment in official correspondence.
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