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
- [email protected]
- Phone
- 630 2702921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Absorbable, Natural | GAL | Class 2 | General, Plastic Surgery | No | 2026-03-10 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2006-02-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2024-06-10 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2008-12-15 |
| Light Source, Photographic, Fiberoptic | FCR | Class 2 | Gastroenterology, Urology | No | 2025-12-19 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt | PTX | Class 2 | General, Plastic Surgery | No | 2021-10-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-06-10 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2026-06-08 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-11-30 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-06-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2007-12-01 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2025-12-19 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2008-12-15 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2025-12-19 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2024-06-10 |
| Suture, Nonabsorbable | GAO | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Suture, Nonabsorable, Ophthalmic | HMN | Class 3 | Unknown | No | 2014-02-10 |
| Suture, Nonabsorbable, Synthetic, Polyester | GAS | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Suture, Absorbable, Synthetic | GAN | Class 2 | General, Plastic Surgery | No | 2014-02-10 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2024-01-25 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2024-06-10 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 2026-02-12 |
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