Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012365569

FEI Number

3012365569

Entity Name

SAINT-GOBAIN PERFORMANCE PLASTICS L+S GMBH

City/State/Country

Neuhaus am Rennweg Thuringia, DE

Establishment Address

Am Herrnberg 8, Neuhaus am Rennweg Thuringia 97824, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Saint-Gobain Performance Plastics L+S GmbH (Owner Number: 10051259)

Owner / Operator Contact Address

Am Herrnberg 8, Neuhaus am Rennweg, DE-TH 98724, DE

Initial Importer Flag

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
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2016-02-24

Official Correspondent

Sascha Krumbein

US Agent Details

Dannelle Lao Business: Saint-Gobain Performance Plastics Email: Dannelle.Lao@saint-gobain.com Phone: (727) 7989026

Related Public Records

Same Entity

Saint-Gobain Performance Plastics L+S GmbH

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012365569. Last updated year: 2026. Please use registration number 3012365569 when referencing this establishment in official correspondence.