EPFLEX FEINWERKTECHNIK GMBH

FDA Device Registration & Listing · DETTINGEN/ERMS Baden-Wurttemberg, DE · Registration 3003289691

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
3003289691
FEI Number
3003289691
Entity Name
EPFLEX FEINWERKTECHNIK GMBH
City/State/Country
DETTINGEN/ERMS Baden-Wurttemberg, DE
Establishment Address
IM SCHWOELLBOGEN 24, DETTINGEN/ERMS Baden-Wurttemberg 72581, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
EPFLEX FEINWERKTECHNIK GMBH (Owner Number: 9087185)
Owner / Operator Contact Address
IM SCHWOELLBOGEN 24, --, DETTINGEN/ERMS, DE-BW D 72581, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Prelude Small O.D. Introducer Guide Wire Soprano® Dual Flex PTFE-Nitinol Guidewire with Straight Hydrophilic Tip Soprano® PTFE-Nitinol Guidewire with Straight Hydrophilic Tip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-11-28
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2020-04-07
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2015-08-13
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-04
FGO Dislodger, Stone, Flexible Gastroenterology, Urology Class 2 876.4680 2009-09-14
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-05

Official Correspondent

Dr. Johannes Uihlein

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

EPFLEX FEINWERKTECHNIK GMBH
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
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0006-2013 US Endoscopy Group Inc 2
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003289691. Last updated year: 2026. Please use registration number 3003289691 when referencing this establishment in official correspondence.
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