Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016785268

FEI Number

3016785268

Entity Name

SIA Elas Baltic

City/State/Country

Jelgava, LV

Establishment Address

Atmodas Iela 19, Jelgava 3001, LV

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Elas A/S (Owner Number: 10064841)

Owner / Operator Contact Address

Industrivej Nord 1, Herning, DK-82 7400, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Brava Sensura Mio Peristeen

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXB	Collector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-04-06
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	Class 2	876.5980	2020-04-06

Official Correspondent

Kresten Karlsen

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

Elas A/S

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
K900590	Biosearch Medical Products, Inc.	BIOSEARCH DOBBHOFF(R) GASTROTRAC JEJUNAL FEEDING	1990-08-02
K102548	Footprint Medical, Inc.	FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE	2010-11-26
K955248	United States Endoscopy Group, Inc.	U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT	1996-05-21
K872921	Medical Support, Inc.	MSS ENTERAL DELIVERY SET	1987-12-03
K180622	Covidien	Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port	2018-10-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2012	Convatec Inc.	1	Natura Durahesive ConvaTec Moldable Technology Post-Operative /Surgical System (57 mm) Required for application to a patient immediately after ostomy surgery.

Similar Registrations

Registration Number	Establishment Name	Location
1513988	KUTOL PRODUCTS COMPANY	Sharonville, OH, US
3006131984	SEISA MEDICAL INC	El Paso, TX, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3011707784	CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.	Changshu Jiangsu, CN
3008244559	CASEX, LTDA	Curitiba Parana, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016785268. Last updated year: 2026. Please use registration number 3016785268 when referencing this establishment in official correspondence.