FDA Registration Active 🇩🇪 Germany

BENTLEY INNOMED GMBH

Reg #: 3009128730 · FEI: 3009128730 · Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1

Registration Details

Registration Name
BENTLEY INNOMED GMBH
Registration Number
3009128730
FEI Number
3009128730
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Lotzenaecker 3
City
Hechingen Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K211802

Owner / Operator

Firm Name
Bentley InnoMed GmbH
Operator Number
10087691
Address
Lotzenaecker 3
City
Hechingen
State
Baden-Wurttemberg
Postal Code
72379
Country
DE

US Agent

Business Name
Bentley USA Inc.
Contact Name
Ben St Jean
Address
222 International Drive, Suite 160
City
Portsmouth
State
NH
ZIP
03801
Country
US
Phone
603 2055772

Products

Device Name Product Code
Catheter For Crossing Total Occlusions PDU

Proprietary Names

BeBack crossing catheter

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility