STIHLER ELECTRONIC GMBH

FDA Device Registration & Listing · Leinfelden-Echterdingen Baden-Wurttemberg, DE · Registration 9617473

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
9617473
FEI Number
3001733054
Entity Name
STIHLER ELECTRONIC GMBH
City/State/Country
Leinfelden-Echterdingen Baden-Wurttemberg, DE
Establishment Address
Gaussstrasse 4, Leinfelden-Echterdingen Baden-Wurttemberg 70771, DE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
STIHLER ELECTRONIC GMBH (Owner Number: 9036252)
Owner / Operator Contact Address
Gaussstrasse 4, --, Leinfelden-Echterdingen Baden-Wurttember, DE-NOTA 70771, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202197
PMA Number
N/A

All Registered Proprietary Names

PRISMAFLO, PRISMAFLO II ASTOTHERM PLUS, ASTOTUBE, ASTOLINE M77455502 M77432002 PRISMATHERM II Prismaflo II Prismaflo IIS ASTOPAD Patient Warming System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2007-12-05
LGZ Warmer, Thermal, Infusion Fluid General Hospital Class 2 880.5725 2007-12-05
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2007-12-05
BSB Warmer, Blood, Non-Electromagnetic Radiation Hematology Class 2 864.9205 2007-12-05
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2009-02-14
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2020-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

Angie Gegner Business: Gentherm Medical Email: angie.gegner@gentherm.com Phone: (513) 3265228

Related Public Records

Same Entity

STIHLER ELECTRONIC 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
K090508 Belmont Instrument Corp. THE BELMONT BUDDY LITE FLUID WARMER 2009-03-26
K171373 3M Company 3M Bair Hugger Model 675 Total Temperature Management System 2017-10-10
K083336 Smiths Medical Asd, Inc. LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL 2009-06-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2010 Cincinnati Sub-Zero Products Inc 2
WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.

Similar Registrations

Registration Number Establishment Name Location
3023981687 Erika of Texas Pharr, TX, US
9611824 FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH SCHWEINFURT Bavaria, DE
8030665 ERIKA DE REYNOSA, S.A. DE C.V. CD, REYNOSA Tamaulipas, MX
2020550 KARL STORZ ENDOSCOPY-AMERICA, INC. Auburn, MA, US
3003464075 NXSTAGE MEDICAL, INC. LAWRENCE, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617473. Last updated year: 2026. Please use registration number 9617473 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.