Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013515223

FEI Number

3013515223

Entity Name

T.K. India Pvt. Ltd.

City/State/Country

Chandigarh, IN

Establishment Address

Plot No. 346-347, Industrial Area Phase 2, Chandigarh 160 002, IN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Teleflex (Owner Number: 9062981)

Owner / Operator Contact Address

3015 Carrington Mill Blvd., Morrisville, NC 27560, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K062523

PMA Number

N/A

All Registered Proprietary Names

EquipLite Standard Laryngoscope Blades and Handles Rusch GreenLite Shucman 2 DispoLED DispoGrip GreenSpec EquipLED TruLED TruLite Secure GreenLED Fiber Optic Laryngoscope Blades and Handles Dolphin SnapLight Rusch Polaris Rusch MRI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2005-03-03
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2017-02-27

Official Correspondent

Divya Raman

US Agent Details

Divya Raman Business: Teleflex, Inc. Email: FDA.US.Agent@Teleflex.com Phone: (612) 4231738

Related Public Records

Same Entity

Teleflex

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004365956	Teleflex Medical de Mexico, S. de R.L. de C.V.	NUEVO LAREDO Tamaulipas, MX
3010041511	Teleflex LLC (NADC)	Olive Branch, MS, US
3007134520	TELEFLEX MEDICAL	ATHLONE Westmeath, IE
8040412	Teleflex Medical Sdn. Bhd.	KAMUNTING Perak, MY
3005232773	Teleflex Medical OEM LLC	Plymouth, MN, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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3019784580	AIMD INC.	Seoul, KR
3004530184	ANDERSEN CALEDONIA LTD	Bellshill Scotland, GB
1824226	KING SYSTEMS CORPORATION.	Noblesville, IN, US
9681384	Covidien	Ciudad Juarez Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013515223. Last updated year: 2026. Please use registration number 3013515223 when referencing this establishment in official correspondence.