Eurofins STERIPAC GMBH

FDA Device Registration & Listing · Calw-Altburg Baden-Wurttemberg, DE · Registration 3009217531

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
3009217531
FEI Number
3009217531
Entity Name
Eurofins STERIPAC GMBH
City/State/Country
Calw-Altburg Baden-Wurttemberg, DE
Establishment Address
Eurofins STERIPAC GMBH, Oberreichenbacherstr. 15-17, Calw-Altburg Baden-Wurttemberg 75365, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STERIPAC GMBH (Owner Number: 10042503)
Owner / Operator Contact Address
STERIPAC GMBH, Oberreichenbacherstr. 17, Calw-Altburg, DE-BW 75365, 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
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2023-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-15
HCH Clip, Aneurysm Neurology Class 2 882.5200 2019-12-16
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2019-12-12
FQH Lavage, Jet General Hospital Class 2 880.5475 2020-12-17
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2025-12-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2025-12-18
KNQ Dilator, Esophageal Gastroenterology, Urology Class 2 876.5365 2019-12-12
NQO Prosthesis, Spinous Process Spacer/Plate Unknown Class 3 N/A 2012-12-04
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-19
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2020-12-17
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2020-12-17
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2019-12-16
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2020-12-17
KOA Surgical Instruments, G-U, Manual (And Accessories) Gastroenterology, Urology Class 1 876.4730 2019-12-12
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2024-12-17
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-19
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2023-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-12-17
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-12-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-12-12
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2018-12-19
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2019-12-12
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2019-12-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-12-16
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-12-15
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2023-12-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-12-15
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2025-12-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-19
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2019-12-12
GCP Endoscope, Ac-Powered And Accessories Gastroenterology, Urology Class 2 876.1500 2019-12-12
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-12-16
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-18
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2023-12-15
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-15
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-15
ETA Replacement, Ossicular Prosthesis, Total Ear, Nose, Throat Class 2 874.3495 2019-12-12
HCH Clip, Aneurysm Neurology Class 2 882.5200 2019-12-16
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2025-12-18
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-15
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-16
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2019-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-12-12
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-19
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-12-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-12-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-12-19
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-12-18
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2025-12-18
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2025-12-18
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-19
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
MQE Needle, Assisted Reproduction Obstetrics/Gynecology Class 2 884.6100 2019-12-16
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2019-12-12
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2019-12-16
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-12-18
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2018-12-19
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2019-12-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2019-12-12
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2019-12-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-12-15
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2017-12-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-12-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-12-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-12-18
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2019-12-12
PKL Hemostatic Metal Clip For The Gi Tract Gastroenterology, Urology Class 2 876.4400 2019-12-12
FDI Snare, Flexible Gastroenterology, Urology Class 2 876.4300 2019-12-12
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-19
NGY Cannula, Trocar, Ophthalmic Ophthalmic Class 1 886.4350 2025-12-18
HTW Bit, Drill Orthopedic Class 1 888.4540 2019-12-12
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2025-12-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-12-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-12-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-12-15
ETB Prosthesis, Partial Ossicular Replacement Ear, Nose, Throat Class 2 874.3450 2019-12-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-01-08
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2023-12-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-12-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-12-17
KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) Ear, Nose, Throat Class 2 874.3620 2019-12-12
QAG Endoscopic Electrosurgical Clip Cutting System Obstetrics/Gynecology Class 2 876.4310 2019-12-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-12-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-12-19
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2020-12-17

Official Correspondent

Bettina Wappler

US Agent Details

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

Related Public Records

Same Entity

STERIPAC 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
K936071 Smith & Nephew Dyonics, Inc. SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE 1994-08-19
K953574 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER 1995-09-29
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009217531. Last updated year: 2026. Please use registration number 3009217531 when referencing this establishment in official correspondence.
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