Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014201171

FEI Number

3014201171

Entity Name

KLS Martin Malaysia Sdn. Bhd.

City/State/Country

Simpang Ampat Pulau Pinang, MY

Establishment Address

No. 1193, Lorong Perindustrian Bukit Minyak 11, Kawasan Perindustrian Bukit Minyak, Simpang Ampat Pulau Pinang 14100, MY

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KLS Martin SE & Co. KG (Owner Number: 10089006)

Owner / Operator Contact Address

KLS Martin Platz 1, Tuttlingen, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2023-10-27
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2023-10-30
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2023-10-30
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2023-10-27
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2023-10-30
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2023-10-27
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2023-10-30
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2023-10-27
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-10-27
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-10-27
HTX	Rongeur	Orthopedic	Class 1	888.4540	2023-10-27
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-10-27
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-10-30
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-10-30
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2023-10-30
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-10-30
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2023-10-30
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2023-10-27
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2023-10-27
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-10-27
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2023-10-27
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2023-10-27
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-10-27
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2023-10-27
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2023-10-27
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-10-27
HXB	Probe	Orthopedic	Class 1	888.4540	2023-10-27
EJY	Pliers, Operative	Dental	Class 1	872.4565	2023-10-30
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2023-10-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-10-27
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2023-10-27
NNU	Scissors, Wire Cutting, Ent, Non-Sterile	Ear, Nose, Throat	Class 1	874.3540	2023-10-30
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2023-10-27

Official Correspondent

No official correspondent registered.

US Agent Details

Melissa Bachorski Business: KLS-Martin L.P. Email: raqa-admin_na@klsmartin.com Phone: (800) 6251557

Related Public Records

Same Entity

KLS Martin SE & Co. KG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681383	KLS Martin SE & Co. KG	Freiburg Baden-Wurttemberg, DE
9610905	KLS Martin SE & Co. KG	Muhlheim/Donau Baden-Wurttemberg, DE
3036795921	KLS MARTIN SE & CO. KG	Fridingen Baden-Wurttemberg, DE
1057946	KLS-Martin L.P.	Jacksonville, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

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3015895045	Sklar Corporation - Warehouse	Salisbury, MD, US
3007603855	KARDIUM Inc.	Burnaby British Columbia, CA
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014201171. Last updated year: 2026. Please use registration number 3014201171 when referencing this establishment in official correspondence.