Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026057410

FEI Number

3026057410

Entity Name

HANISCH MEDICAL LTDA

City/State/Country

Portao Rio Grande do Sul, BR

Establishment Address

RODOVIA RS 240 n.41 Km 06, LOTEAMENTO ARCO IRIS, Portao Rio Grande do Sul 93180-000, BR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HANISCH MEDICAL LTDA (Owner Number: 10090104)

Owner / Operator Contact Address

RODOVIA RS 240 n.41 Km 06, LOTEAMENTO ARCO IRIS, Portao, BR-RS 93180-000, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KIRSCHNER TUBE-INOX 3/8 H49-TRAY F/INST.STANDER---BEIGE LID HL26-17 F/INST.-STANDER--- AMBER H45-BOX F/INST.STANDER---GRAY H37-BOX(90) F/INST.STANDER---BEIGE H45-BOX F/INST.STANDER---BEIGE H19-9-6-0B-CASE F/ INST.-STANDER---BEIGE/AMBER H45-LID F/INST.STANDER---SMOKE H49-TRAY(70) F/ INST.-STANDER C -GRAY/SMOKE H52-BOX(100) F/INST.STANDER---BLUE HO8-LID(37-50) F/ DRILLS.-STANDER---GREEN H52-LID F/INST.STANDER---BLUE HO8-LID(37-50) F/ DRILLS.-STANDER---AMBER HL26-26-LID F/IMPL.STANDER---BLUE HL26-17-TRAY(25)F/IMPL.STANDER---BEIGE H28-BOX(140) F/INST.STANDER---BEIGE HL26-26-TRAY(25)F/IMPL.STANDER---BEIGE H49-LID F/INST.STANDER---BLUE HL26-17-TRAY(120) F/ PARAF.-STANDER---BEIGE HL26-26-LID F/IMPL.STANDER---AMBER H37-TRAY(30) F/INST.STANDER---BEIGE HO8-BASE(37-50) F/ DRILLS.-STANDER---BEIGE HO8-BASE(37-50) F/ DRILLS.-STANDER---WHITE HO8-LID(37-50) F/ DRILLS.-STANDER---SMOKE H52-LID F/INST.STANDER---BEIGE HL26-17-LID F/INST.-STANDER---SMOKE H18-13-6-1B-CASE F/INST.-STANDER---WHITE/AMBER H45-LID F/INST.STANDER---AMBER H39-BOX(110) F/INST.STANDER---BEIGE H49-LID F/ INST.-W/CLIP GRAY-STANDER---SMOKE H45-LID F/ INST.-STANDER---BLUE H52-LID F/INST.STANDER---AMBER HL26-17-120-Sterilization Box H39-110-Sterilization Box H49-70-Sterilization Box H45-50-Sterilization Box HL26-26-120-Sterilization Box HL26-26-25-Sterilization Box H32-25-Sterilization Box H28-70-Sterilization Box H18-13-6-Sterilization Box H52-160-Sterilization Box HL26-17-25-Sterilization Box H52-100-Sterilization Box H37-90-Sterilization Box H14-63-50-Sterilization Box H12-9-6-Sterilization Box H49-100-Sterilization Box H26-40-Sterilization Box H19-9-6-Sterilization Box H23-17-6-Sterilization Box H65-80-Sterilization Box H23-17-6-1B-CASE F/ INST.-STANDER-BEIGE/AMBER H52-LID F/TRAY F/ INST.-STANDER---BEIGE H65-BOX(80) F/ INST.-STANDER---BEIGE H52-LID F/ INST.-STANDER---SMOKE HO8-LID(37-50) F/ DRILLS.-STANDER---RED HL26-26-TRAY(120) F/ PARAF.-STANDER---BEIGE H49-BOX(70) F/INST.STANDER---BEIGE H28-140-Sterilization Box H26-LID F/INST.STANDER---AMBER H49-BOX(100) F/INST.STANDER---BEIGE HO8-BASE(37-50) F/ DRILLS.-STANDER---BLACK H52-BOX(100) F/INST.STANDER---GRAY H65-LID F/ INST.-STANDER---AMBER HO8-LID(37-50) F/ DRILLS.-STANDER---BLUE H28-LID F/INST.STANDER---AMBER H28-TRAY(70) F/ INST.-STANDER E ---GRAY/SMOKE H37-LID F/INST.STANDER---AMBER H12-9-6-1B-CASE F/ IMP.-STANDER---WHITE/AMBER H52-TRAY F/INST.STANDER---BEIGE H49-LID F/INST.STANDER---AMBER H45-LID F/INST.STANDER---LILAC H28-LID F/INST.STANDER---SMOKE H28-BOX(70) F/INST.STANDER---BEIGE H49-TRAY F/INST.STANDER---GRAY HO8-LID(37-50) F/ DRILLS.-STANDER---LILAC H52-BOX(100) F/INST.STANDER---BEIGE H52-BOX(160) F/INST.STANDER---BEIGE H28-LID F/INST.STANDER---BLUE H26-BOX F/INST.STANDER---BEIGE H32-LID F/INST.STANDER---AMBER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2024-08-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2024-02-15

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

HANISCH MEDICAL LTDA

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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

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3016171961	HANGZHOU ALLINE PLASTIC CO., LTD.	HANGZHOU Zhejiang, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026057410. Last updated year: 2026. Please use registration number 3026057410 when referencing this establishment in official correspondence.