FDA Registration Active 🇦🇹 Austria

Realize Adjustable Gastric Band-C

Reg #: 3003744503 · FEI: 3003744503 · Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1

Registration Details

Registration Name
MEDISCAN GMBH & CO. KG, STERILISATIONSANLAGE SEIBE
Registration Number
3003744503
FEI Number
3003744503
Status
Active
Expiry Year
2025
Initial Importer
No
Address
IM FORSCHUNGSZENTRUM
City
SEIBERSDORF Niederosterreich
Country
AT

Regulatory Submissions

PMA Number
P070009

Owner / Operator

Firm Name
MEDISCAN GMBH & CO. KG
Operator Number
9033053
Address
BAD HALLER STRASSE 34, --
City
KREMSMUNSTER
State
Oberosterreich
Postal Code
A-4550
Country
AT

US Agent

Business Name
GREINER BIO-ONE NORTH AMERICA, INC.
Contact Name
Manfred Abel
Address
4238 Capital Drive
City
Monroe
State
NC
ZIP
28110
Country
US
Phone
704 2617821

Products

Device Name Product Code
Implant, Intragastric For Morbid Obesity LTI

Proprietary Names

Realize Adjustable Gastric Band-C Realize Injection Port and Applier Realize Adjusteable Gastric Band

Establishment Types

Sterilize Medical Device for Another Party (Contract Sterilizer)