Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004944585

FEI Number

3004944585

Entity Name

HEALTHIUM MEDTECH LIMITED

City/State/Country

BANGALORE Karnataka, IN

Establishment Address

472/D, 13TH CROSS, 4TH PHASE, PEENYA INDUSTRIAL AREA, BANGALORE Karnataka 560058, IN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

HEALTHIUM MEDTECH LIMITED (Owner Number: 9064005)

Owner / Operator Contact Address

472/D, 13TH CROSS, 4TH PHASE, PEENYA INDUSTRIAL AREA, BANGALORE, IN-KA 560058, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223889

PMA Number

N/A

All Registered Proprietary Names

TRULENE MESH Premisut Polypropylene Mesh ObereMESH LINX MESH LINX LAPROMESH Sterile Non-Absorbable Surgical Polypropylene Mesh Knee Probe Premisut PGCL MONOPRONE MONOGLYDE LINX MONO Flysorb Mono Poliglecaprone 25 Monofilament Poliglecaprone 25 U-Monoglyde Visualization system 4K - Light Source Visualization system 4K-Light Cable TRUSTEEL U-Steel Monofilament 316 LVM Stainless steel Cannula Introducer-6mm Lasso 90 Degree Left ICR AWL Horizontal 2.4mm Metal Screw Driver 12.5° Curved Sleeve 1.5mm anchor Meniscal Repair Cannula - Up/Down Cannulated Tunnel Dilator 9mm 25° Curved Sleeve 1.8mm Anchor ACL Aimer 2 point Lock Knob Lasso 25 Degree Right RASP Convex Taper peg (8-9) ACL JIG 3 point Bullet Straight Sleeve 1.8mm Anchor T-Handle for Tunnel Dilator Straight Sleeve 1.5mm anchor Suture Passer Needle -mini Micro Fracture AWL - 45 degree Button Holder with Suture Tightning post Cannulated Quick Coupling T Handle ACL Femoral Aimer 7 Meniscal Repair Cannula - Down bend Straight Rasp ACL JIG 3 point Tibial Aimer/Arm Cannulated Tunnel Dilator 8mm Rasp - Half Round Lasso 25 Degree Left Curette Up bend ACL Femoral Aimer 5 Meniscal Repair Cannula - Left/Right PCL ELEVATOR Meniscal Repair Cannula - Double lumen 12.5° Curved Sleeve 1.8mm anchor ACL JIG 2 point Complete Set SUTURE CUTTER Graft Master system with Tensioner Guidewire 1.2 mm Meniscal open cannula Suture Passer-mini Universal Guiding cannula Lasso 90 Degree Right Suture Passer-Shoulder ACL JIG 2 point Aimer Holder- Handle Meniscal knot pusher cutter Cannulated Tunnel Dilator 7mm Lasso Straight Guiding Cannula 2.5-2.8mm Micro Fracture AWL - 90 degree Guidewire 1.5 mm Instrument Box and Tray Taper peg (7-8) Meniscal Repair Cannula - single lumen 25° Curved Sleeve 1.5mm anchor ACL JIG 2 point Tibial Aimer/Arm Mallet Lasso 45 Degree Left ACL JIG 2 point Bullet Cannula Introducer -8mm Lasso 45 Degree Right Graft gauge/ sizing block Curette Down Bend ACL Femoral Aimer 6 Meniscal Repair Cannula- Up Bend ICR AWL Vertical 3.5mm Bio Screw driver Small Straight Tap 4.8 mm Guidewire 2 mm Meniscus Diamond Rasp Taper peg (9-10) ACL Aimer 3 point Lock Knob Straight Awl 4.8 mm Guide Wire Dia-1.8mm Straight Awl 5.5 mm GUIDE WIRE 10MM DIA T-Button Dilator ACL JIG 3 point Aimer Holder- Handle Micro Fracture AWL - 30 degree Suture Passer Needle-Shoulder Straight Tap 5.5 mm Bio Screw driver large Screw Starter ACL JIG Complete Set Sterile needle bending tool Needle Bending Tool T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button Reamer TRUBOND X-BOND LINX BOND Polytek Braided and Coated Polyester Premisut Polyester Polyester U-Bond Visualization system 4K - Camera head LINX PDO ObereDEX PD Synth Monofilament Polydioxanone Polydioxanone Premisut PDO U-PD Synth Visualization system 4K - Console TRUSYNTH PREMISUT PGLA-910 LINX GLACTIN 910 Braided and Coated Polyglactin 910 Polyglactin 910 U-Synth Surestitch UHMWPE suture PEEK Button Meniscus Repair Implant XL - Flexible needle Securefix UHMWPE suture PEEK Button Meniscus Repair Implant XL - Flexible needle Surestitch UHMWPE suture PEEK Button Meniscus Repair Implant Flexible needle SURE FIX Securefix UHMWPE suture PEEK Button Meniscus Repair Implant Flexible needle Securefix SURESTITCH UHMWPE Suture PEEK Button Meniscus Repair Implant CEPTRE® Knotted UHMWPE Suture PEEK Anchor Disposable Drill 2.8 mm anchor Disposable Flexible Drill 2 mm Anchor Disposable Drill 1.2mm Anchor Disposable Anchor Drill 2.9mm for Self Tap Disposable Drill 1mm Anchor Disposable Drill 2.5 mm anchor Cannulated Femoral Drill 11 mm Cannulated Tibial Drill 7.5 mm Cannulated Tibial Drill 9 mm Spade Tip Drill 3.25 mm Cannulated Femoral Drill 5 mm Drill 1.5mm Anchor Cannulated Tibial Drill 10.5 mm Drills Cannulated Tibial Drill 10 mm Cannulated Femoral Drill 6.5 mm Cannulated Femoral Drill 7.5 mm Drill 2.8 mm anchor Cannulated Drill 4.75 mm Cannulated Femoral Drill 12 mm Drill Bit 2.4 mm Cannulated Femoral Drill 6 mm Drill 2.4 mm Knotless anchor Cannulated Tibial Drill 8.5 mm Flexible Drill 1.7 mm anchor Cannulated Tibial Drill 12 mm Flexible Drill 1.5 mm anchor Cannulated Tibial Drill 11 mm Flexible Drill 1.8 mm Anchor Cannulated Tibial Drill 9.5 mm Cannulated Femoral Drill 8 mm Cannulated Tibial Drill 8 mm Flexible Drill 2 mm Anchor Drill 2.5 mm anchor Disposable Drill 1.5mm Anchor Cannulated Femoral Drill 10.5 mm Cannulated Tibial Drill 7 mm Cannulated Femoral Drill 9.5 mm Cannulated Tibial Drill 6 mm Cannulated Femoral Drill 5.5 mm Drill 1.8mm Anchor Disposable Cannulated Femoral Drill 4.5mm Cannulated Femoral Drill 8.5 mm Disposable Passing Pin 2.4 mm Disposable Drill Bit 2.4 mm Cannulated Femoral Drill 9 mm Disposable Drill 2.4 mm Knotless anchor Cannulated Drill 4.5mm Disposable Anchor Drill 2.5mm for Self Tap Cannulated Femoral Drill 7 mm Cannulated Femoral Drill 10 mm Cannulated Tibial Drill 6.5mm Disposable Spade Tip Drill 3.25 mm Spade Tip Drill 4.5 mm Disposable Flexible Drill 1.5 mm anchor Disposable Drill 1.8mm Anchor Disposable Flexible Drill 1.7 mm anchor Disposable Drill 2mm Anchor Disposable Drill 2.2mm Anchor Disposable Flexible Drill 1.8 mm Anchor Disposable Spade Tip Drill 4.5 mm SOFT LOCK Stativ® Knotted UHMWPE Suture Anchor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2026-03-10
FTL	Mesh, Surgical, Polymeric	General, Plastic Surgery	Class 2	878.3300	2006-02-22
HXB	Probe	Orthopedic	Class 1	888.4540	2024-06-10
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-12-15
FCR	Light Source, Photographic, Fiberoptic	Gastroenterology, Urology	Class 2	876.1500	2025-12-19
PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt	General, Plastic Surgery	Class 2	878.4495	2021-10-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-06-10
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2026-06-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-30
HTO	Reamer	Orthopedic	Class 1	888.4540	2024-06-10
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-12-01
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2025-12-19
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2008-12-15
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2025-12-19
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-12-15
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-01-25
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-01-25
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2024-06-10
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2023-11-30

Official Correspondent

PANKAJ DAWAR

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

HEALTHIUM MEDTECH LIMITED

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680258	HEALTHIUM MEDTECH LIMITED	GAUTAMBUDH NAGAR, NOIDA Uttar Pradesh, IN
3020983460	HEALTHIUM MEDTECH LIMITED	SRI CITY Andhra Pradesh, IN
9680889	PARAMOUNT SURGIMED LTD.	BHIWADI Rajasthan, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220540	Covidien	ProGrip Self-Gripping Polypropylene Mesh	2022-09-22
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004944585. Last updated year: 2026. Please use registration number 3004944585 when referencing this establishment in official correspondence.