FDA Registration Active 🇮🇳 India

HEALTHIUM MEDTECH LIMITED

Reg #: 3004944585 · FEI: 3004944585 · Expires 2026
Products
25
Proprietary Names
264
Establishment Types
2
Classifications
25

Registration Details

Registration Name
HEALTHIUM MEDTECH LIMITED
Registration Number
3004944585
FEI Number
3004944585
Status
Active
Expiry Year
2026
Initial Importer
No
Address
472/D, 13TH CROSS, 4TH PHASE, PEENYA INDUSTRIAL AREA
City
BANGALORE Karnataka
Country
IN

Regulatory Submissions

510(k) Number
K911354

Owner / Operator

Firm Name
HEALTHIUM MEDTECH LIMITED
Operator Number
9064005
Address
472/D, 13TH CROSS, 4TH PHASE, PEENYA INDUSTRIAL AREA
City
BANGALORE
State
Karnataka
Postal Code
560058
Country
IN
Correspondent
PANKAJ - DAWAR

US Agent

Business Name
Liberty Management Group Ltd.
Contact Name
Manoj Zacharias
Address
75 Executive Drive,, Suite 114,
City
Aurora
State
IL
ZIP
60504
Country
US
Phone
630 2702921

Products

Device Name Product Code
Suture, Absorbable, Natural GAL
Mesh, Surgical, Polymeric FTL
Probe HXB
Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
Light Source, Photographic, Fiberoptic FCR
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt PTX
Orthopedic Manual Surgical Instrument LXH
Instrument, Bending Or Contouring HXP
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Reamer HTO
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Camera, Surgical And Accessories KQM
Suture, Surgical, Absorbable, Polydioxanone NEW
Camera, Television, Endoscopic, Without Audio FWF
Bit, Drill HTW
Suture, Nonabsorbable GAO
Suture, Nonabsorbable, Silk GAP
Suture, Nonabsorbable, Synthetic, Polypropylene GAW
Suture, Nonabsorbable, Synthetic, Polyamide GAR
Suture, Nonabsorable, Ophthalmic HMN
Suture, Nonabsorbable, Synthetic, Polyester GAS
Suture, Absorbable, Synthetic GAN
Stripper, Surgical HRT
Gauge, Depth HTJ
Applier, Surgical, Clip GDO

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 U-Lene TRULENE CARDIOPILENE LINX PROLINE Monofilament Polypropylene Polypropylene Premisut Polypropylene Sterile Guidewire Sterile Meniscus Repair Cannula (Single use) Sterile Suture Passer (Single use) Sterile Guidewire (Single use) Sterile Suture Cutter (Single use) TENDON STRIPPER- OPEN TENDON STRIPPER OPEN 8 mm TENDON STRIPPER- CLOSED TENDON STRIPPER CLOSED 5mm TENDON STRIPPER OPEN 7mm TENDON STRIPPER CLOSED 7mm Sleeve for 2.5 mm / 2.9 mm for self-tap dispenser TENDON STRIPPER CLOSED 8mm TENDON STRIPPER OPEN 6mm Sterile Guiding cannula Sterile Meniscus Repair Cannula Sleeve straight 1.5 mm anchor Sterile Lasso (with and without Rollers) Sterile Suture Passer Sterile Lasso (with and without roller versions) (Single use) TENDON STRIPPER CLOSED 6mm Sterile Guiding cannula (Single use) Sterile Suture Passer Needle (Single use) Sterile Suture Passer Needle TENDON STRIPPER OPEN 5mm Sterile Suture Cutter Sterile Meniscal Knot Pusher Cutter Sterile Meniscal Open - Cannula U-Silk TRUSILK LINX SILK ObereSILK Silk Black Braided Silk Premisut Silk INFILOOP® Fixed Loop UHMWPE Suture Titanium Button DEPTH GUAGE Meniscus Depth Gauge Premisut Nylon TRULON LINX NYLON ObereLON Monomyd Nylon Monofilament Polyamide (Nylon) U-Lon TRUGLYDE VIPRONE LINX PGA Flysorb Braided and Coated Polyglycolic acid U-Glyde Premisut PGA Polyglycolic Acid Titanium Ligating Clip Applier Trutie Applier

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility