EUROFINS INPAC MEDIZINTECHNIK GMBH

FDA Device Registration & Listing · Birkenfeld Baden-Wurttemberg, DE · Registration 3013111980

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
3013111980
FEI Number
3013111980
Entity Name
EUROFINS INPAC MEDIZINTECHNIK GMBH
City/State/Country
Birkenfeld Baden-Wurttemberg, DE
Establishment Address
Neureutstrasse 4, Birkenfeld Baden-Wurttemberg 75217, DE
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Eurofins inpac Medizintechnik GmbH (Owner Number: 10043226)
Owner / Operator Contact Address
Gewerbestrasse 34, Birkenfeld, DE-BW 75217, 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
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-02-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-05-19
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2013-01-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-06-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2015-04-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-02-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-02-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-07-02
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2015-08-03
HBL Holder, Head, Neurosurgical (Skull Clamp) Neurology Class 2 882.4460 2017-04-11
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2018-09-05
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2013-01-31
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2018-02-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-02-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2025-02-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-16
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2019-05-03
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2019-05-03

Official Correspondent

Lisa Heilemann

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Eurofins inpac Medizintechnik GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007515069 EUROFINS INPAC MEDIZINTECHNIK GMBH Birkenfeld Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013111980. Last updated year: 2026. Please use registration number 3013111980 when referencing this establishment in official correspondence.
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