Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020983460

FEI Number

3020983460

Entity Name

HEALTHIUM MEDTECH LIMITED

City/State/Country

SRI CITY Andhra Pradesh, IN

Establishment Address

PLOT NO.1605, Portia Road, Sri City, Tirupati District, SRI CITY Andhra Pradesh 517 646, IN

Establishment Type(s)

Manufacture Medical Device

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

K081003

PMA Number

N/A

All Registered Proprietary Names

Premisut PGCL MONOPRONE MONOGLYDE LINX MONO Flysorb Mono Poliglecaprone 25 Monofilament Poliglecaprone 25 U-Monoglyde TRUGLYDE VIPRONE LINX PGA Flysorb Braided and Coated Polyglycolic acid U-Glyde Premisut PGA Polyglycolic Acid TRUSTEEL U-Steel Monofilament 316 LVM Stainless steel Premisut Nylon TRULON LINX NYLON ObereLON Monomyd Nylon Monofilament Polyamide (Nylon) U-Lon LINX PDO ObereDEX PD Synth Monofilament Polydioxanone Polydioxanone Premisut PDO U-PD Synth TRUBOND X-BOND LINX BOND Polytek Braided and Coated Polyester Premisut Polyester Polyester U-Bond TRUSYNTH PREMISUT PGLA-910 LINX GLACTIN 910 Braided and Coated Polyglactin 910 Polyglactin 910 U-Synth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-12-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2007-12-01
PTX	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt	General, Plastic Surgery	Class 2	878.4495	2021-10-09
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2007-11-30
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2008-12-15
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2007-12-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-12-15

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
9680889	PARAMOUNT SURGIMED LTD.	BHIWADI Rajasthan, IN
3004944585	HEALTHIUM MEDTECH LIMITED	BANGALORE Karnataka, IN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18

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 3020983460. Last updated year: 2026. Please use registration number 3020983460 when referencing this establishment in official correspondence.