HETTICH AG

FDA Device Registration & Listing · BAECH Schwyz, CH · Registration 3004086278

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
3004086278
FEI Number
3004086278
Entity Name
HETTICH AG
City/State/Country
BAECH Schwyz, CH
Establishment Address
SEESTRASSE 204A, BAECH Schwyz 8806, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HETTICH AG (Owner Number: 9057280)
Owner / Operator Contact Address
SEESTRASSE 204A, --, BAECH, CH-NOTA 8806, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ULTRACW UltraCW®II Automatic Cell Washing System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KSN Centrifuge, Cell-Washing, Automated For Immuno-Hematology Hematology Class 2 864.9285 2006-08-23
KSN Centrifuge, Cell-Washing, Automated For Immuno-Hematology Hematology Class 2 864.9285 2019-05-30

Official Correspondent

No official correspondent registered.

US Agent Details

RENEE SCHULTZ Business: HELMER INC. Email: rschultz@helmerinc.com Phone: (317) 7739073

Related Public Records

Same Entity

HETTICH AG
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004086278. Last updated year: 2026. Please use registration number 3004086278 when referencing this establishment in official correspondence.
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