Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005990076

FEI Number

3005990076

Entity Name

ANDREAS HETTICH GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

FOEHRENSTRASSE 12, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Andreas Hettich GmbH (Owner Number: 9020624)

Owner / Operator Contact Address

Foehrenstrasse 12, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Rotina 380 robotic EBA 200 EBA200S EBA 280S EBA 270 EBA 280 Mikro 185 Blood Bank Centrifuge Rotanta 460 robotic Rotina 380R robotic Rotanta 46 RSC ROTO SILENTA 630RS ROTIXA 500RS Rotofix 32A (MD) Intra-Spin System HettCube Hematocrit Capillaries 2074, Standard, Heparinized Sealing Putty 2077 EBA 280 EBA 200 EBA 200S EBA 280S Hematocrit Rotor 1650 for UNIVERSAL 320 and UNIVERSAL 320 R Hematocrit Rotor 1023 for MIKRO 220 and MIKRO 220 R Hematocrit Rotor 2076 for HAEMATOKRIT 200 Cyto Centrifuge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	Class 1	864.9275	1995-06-01
QBV	Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate	Clinical Chemistry	Class 1	862.2050	2021-04-30
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2021-07-19
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2018-10-19
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	Class 2	864.6400	2016-05-03
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	1995-06-01
JPI	Device, Hematocrit Measuring	Hematology	Class 2	864.6400	2016-05-03
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2006-08-30

Official Correspondent

Darrall Pride

US Agent Details

Darrall Pride Business: HETTICH INSTRUMENTS LP Email: Darrall.Pride@hettweb.com Phone: (978) 5663325

Related Public Records

Same Entity

Andreas Hettich GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005990076. Last updated year: 2026. Please use registration number 3005990076 when referencing this establishment in official correspondence.