ROECHLING MEDICAL WALDACHTAL AG

FDA Device Registration & Listing · Waldachtal Baden-Wurttemberg, DE · Registration 3015488952

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
3015488952
FEI Number
3015488952
Entity Name
ROECHLING MEDICAL WALDACHTAL AG
City/State/Country
Waldachtal Baden-Wurttemberg, DE
Establishment Address
Herbert-Frank Str. 26, Waldachtal Baden-Wurttemberg 72178, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Roechling Medical Waldachtal AG (Owner Number: 10081205)
Owner / Operator Contact Address
Herbert-Frank Str. 26, Waldachtal, DE-BW 72178, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TH001 Cover for VITOM 3D - EPT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2025-05-28
LHI Set, I.V. Fluid Transfer General Hospital Class 2 880.5440 2021-03-25

Official Correspondent

Marie Lechler

US Agent Details

David Leighton Business: Roechling Medical Lancaster Email: david.leighton@roechling-medical.us Phone: (717) 3353700

Related Public Records

Same Entity

Roechling Medical Waldachtal AG
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
K243985 Icu Medical, Inc. Rio™ Drug Reconstitution Transfer Device 2025-01-22
K222718 Hangzhou Qiantang Longyue Biotechnology Co., Ltd. Vial Adapter 2023-03-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2017 Baxter Corporation Englewood 2
0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015488952. Last updated year: 2026. Please use registration number 3015488952 when referencing this establishment in official correspondence.
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