Ubio Biotechnology Systems Pvt.Ltd

FDA Device Registration & Listing · Kalamassery Kerala, IN · Registration 3011878253

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
3011878253
FEI Number
3011878253
Entity Name
Ubio Biotechnology Systems Pvt.Ltd
City/State/Country
Kalamassery Kerala, IN
Establishment Address
ubio Biotechnology Systems Pvt ltd, #15A Biotechnology Zone, Kinfra Hi-Tech Park, Kalamassery Kerala 683503, IN
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ubio Biotechnology Systems Pvt Ltd (Owner Number: 10089502)
Owner / Operator Contact Address
No.15A, Biotechnology Zone, Kinfra Hi-Tech Park, Kalamassery, Ernakulam, IN-KL 683503, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Inito Fertility Monitor Strip Fertility Strip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2023-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

Lilian Llull Business: TechLink International LLC Email: lilian@techlinkusa.net Phone: (305) 2066777

Related Public Records

Same Entity

ubio Biotechnology Systems Pvt Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01

Similar Registrations

Registration Number Establishment Name Location
3013124221 MERIL DIAGNOSTICS PVT. LTD. Vapi Gujarat, IN
3015729142 Winx Health Inc Reading, PA, US
3027500452 TRUE DIAGNOSTICS, INC. Carlsbad, CA, US
3013885851 CENTUM ELECTRONICS LIMITED Bangalore Karnataka, IN
3008054239 CORE TECHNOLOGY CO., LTD. Changping District Beijing, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011878253. Last updated year: 2026. Please use registration number 3011878253 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.