Alleima Karlsruhe GmbH

FDA Device Registration & Listing · Karlsruhe Baden-Wurttemberg, DE · Registration 3007055279

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
3007055279
FEI Number
3007055279
Entity Name
Alleima Karlsruhe GmbH
City/State/Country
Karlsruhe Baden-Wurttemberg, DE
Establishment Address
Wilhelm-Schickard-Str. 9c, Karlsruhe Baden-Wurttemberg 76131, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Alleima Karlsruhe GmbH (Owner Number: 10050443)
Owner / Operator Contact Address
Wilhelm-Schickard-Str. 9c, Karlsruhe, DE-BW 76131, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2015-11-18
DWP Dilator, Vessel, Surgical Cardiovascular Class 2 870.4475 2025-11-24
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2015-11-18
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2019-08-02
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2025-12-12

Official Correspondent

Florian Hauck

US Agent Details

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

Related Public Records

Same Entity

Alleima Karlsruhe 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
K810894 American Edwards Laboratories FOGARTY FLEXIBLE CALIBRATOR 1981-05-15

Similar Registrations

Registration Number Establishment Name Location
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US
3013649990 HEALTH BEACONS, INC. Marlborough, MA, US
3026851515 VDL TBP ELECTRONICS Dirksland Zuid-Holland, NL
3015924373 AUSA Medical Device Pvt Ltd Bangalore Karnataka, IN
2029275 Sterigenics U.S., LLC Corona, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007055279. Last updated year: 2026. Please use registration number 3007055279 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.