Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017882410

FEI Number

3017882410

Entity Name

BIOTECNO INDUSTRIA E COMERCIO LTDA

City/State/Country

SANTA ROSA Rio Grande do Sul, BR

Establishment Address

Rua PIRAPO 613,TIMBAUVA, SANTA ROSA Rio Grande do Sul 98781-054, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BIOTECNO INDUSTRIA E COMERCIO LTDA (Owner Number: 10079980)

Owner / Operator Contact Address

Rua PIRAPO 613,TIMBAUVA, SANTA ROSA, BR-RS 98781-054, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scientific Freezer BT-1300/260 Scientific Refrigerator BT-1100/20 Scientific Refrigerator BT-1100/360 Scientific Freezer BT-1200/10 Scientific Refrigerator BT-1100/50 Scientific Refrigerator BT-1100/240 Scientific Freezer BT-1300/335 Scientific Refrigerator BT-1100/280 Scientific Refrigerator BT-1100/340 Scientific Freezer BT-1300/1500 Scientific Freezer BT-1200/1500 Scientific Refrigerator BT-1100/700 Scientific Refrigerator BT-1100/120 Scientific Refrigerator BT-1100/400 Scientific Freezer BT-1300/1700 Scientific Refrigerator BT-1100/1000 Scientific Refrigerator BT-1100/420 Scientific Freezer BT-1300/520 Scientific Freezer BT-1200/560 Scientific Refrigerator BT-1100/10 Scientific Refrigerator BT-1100/1200 Scientific Freezer BT-1200/140 Scientific Refrigerator BT-1100/600 Scientific Refrigerator BT-1100/800 Scientific Refrigerator BT-1100/350 Scientific Freezer BT-1200/420 Scientific Freezer BT-1200/1000 Scientific Refrigerator BT-1100/500 Scientific Refrigerator BT-1100/1500 Scientific Freezer BT-1200/20 Scientific Refrigerator BT-1100/1700 Scientific Freezer BT-1300/140 Scientific Refrigerator BT-1100/560 Scientific Refrigerator BT-1100/140 Scientific Refrigerator BT-1100/80 Scientific Refrigerator BT-1100/260 Scientific Refrigerator BT-1100/300 Scientific Freezer BT-1200/50 Scientific Refrigerator BT-1100/1350 Scientific Freezer BT-1200/300 Scientific Freezer BT-1200/80 Scientific Refrigerator BT-1100/900 Scientific Refrigerator BT-1100/100 Scientific Freezer BT-1300/1200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KSE	Refrigerator, Freezer, Blood Storage	Hematology	Class 2	864.9700	2021-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

PASSARINI CRO AND REGULATORY SOLUTIONS LLC Email: usagent@passarini.com.br Phone: (786) 8496760

Related Public Records

Same Entity

BIOTECNO INDUSTRIA E COMERCIO LTDA

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 3017882410. Last updated year: 2026. Please use registration number 3017882410 when referencing this establishment in official correspondence.