Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008881803

FEI Number

3008881803

Entity Name

PT. MEGA ANDALAN KALASAN

City/State/Country

JOGYAKARTA Yogyakarta, ID

Establishment Address

JL. TANJUNG TIRTOMARTANI, KALASAN KM 13, JOGYAKARTA Yogyakarta 0000, ID

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PT. MEGA ANDALAN KALASAN (Owner Number: 10035069)

Owner / Operator Contact Address

RASUNA OFFICE PARK, SUITE SO-02, KOMP EPICENTRUM JL. HR RASUNA SAID, JAKARTA, ID-JK 12960, ID

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

31302 Commode chair 31207 Transporting Stretcher; 31208 Emergency Mobile Stretcher; 31218 Emergency Mobile Stretcher; MS301 Patient Stretcher MS302 Patient Stretcher; 31213 Patient Stretcher; 31223 Patient Stretcher; 31201 Folding Stretcher; 31202 Mobile Stretcher; 31203 Mobile Stretcher; 31206 Multipurpose Stretcher 31209 Transferring Stretcher; 31209T Transferring Stretcher with Trendelenburg position; 31209TH Transferring Stretcher 31210 Mortuary Carriage;31214 Emergency Stretcher; 31217 Electric Emergency Stretcher 36101 Infuse Stand; 36103 Infuse Stand; 36108 Infuse Stand; 36163 Infuse Stand 34112 Gynecolog Examination Table, Mild Steel; ME101 Examination Table (knockdown system); ME111 Examination Table; 34202 Gyn Examination Table 34205 Manual Examination Table; ME111FS Examination Table + Foot Step; 34102K Gynecolog Examination table, knockdown system; 34112 Gynecolog Examination Table, Mild Steel ME101FS Examination Table + Foot Step; ME112FS L'De Table + Foot Step; 34110 Gynecologic Examination Chair MK104 Waiting Chair, 4 Seat; MK204 Waiting Chair, 4 Seat; MK103 Waiting Chair, 3 Seat Gynecolog Examination Table, Stainless Steel 34102, 34103, 34109, 34117; 34102K Gynecolog Examination table, knockdown 31309 Multi Functional Chair; Gynecolog Examination Table, Stainless Steel 34102, 34103, 34109, 34117 ME112 L `De Table 34101 Examination Table; 34105 Examination Table; 34112 Gynecolog Examination Table, Mild Steel; 31303*31313 Wheel chair; 31305 Wheel chair; 31310 Wheel chair 52501 M Manual Operating Table *5211M, MO201 33611 Baby Basket - stainless steel; 33619 Baby Basket; MBB01 Baby Bassinet; MBB11 Baby Bassinet 13 33608 Baby Basket - mild steel; 33609 Baby Basket - stainless steel; 33610 Baby Basket - stainless steel 77011 Hydraulic Sotamak Bed; 77002 Manual Crank Hydraulic Sotamak Bed 33605 B Children Bed 33605 C Children Bed; 33606 B Children Bed; 33606 C Children Bed; MBC01 Pediatric Bed; MBC02 Pediatric Bed 33601 B Children Bed; 33601 C Children Bed; 33602 B Children Bed; 33602 C Children Bed 34128 MAK Premium Couch 4-Sections; 34129 MAK Premium Couch 5-Sections; 34121 Premium Plus Podiatry; 34208 Electric Gynaecolog Examination Chair 34126 MAK Premium Plus (Electra) 3-Sections 2 Motors; 34127 MAK Premium Plus (Electra) 3-Sections 3 Motors; 34130 Mak Pro 2 Section; 34131 Mak Pro 3 Section; 34104 E Electric Examination Table; 34118, MAK Premium Changing Table 34118 Premium Couch Changing Table; 34120 Premium Couch 3 Sections; 34207 Electric Gynaecolog Table; 4122 Neurology; 34123 MAK Premium Plus (Solo) 3-Sections; 34125 MAK Premium Plus (Electra) 2-Sections 2 Motors; 34118P MAK Premium Plus Changing Table; 34119 MAK Premium 2 Sections; *34219; 34119P MAK Premium Plus 2 Sections 34120 MAK Premium 3 Sections; 34120P MAK Premium Plus 3 Sections; 34107 Electric Gynecolog Examination Table 34151 Examination Stool; 34152 Foot Step; MA301 Foot Step; 36301 Bowl Stand Single; 36302 Bowl Stand Double

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
INB	Attachment, Commode, Wheelchair	Physical Medicine	Class 1	890.3920	2011-05-20
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2011-05-19
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2011-05-19
FRK	Chair, Examination And Treatment	General Hospital	Class 1	880.6140	2011-05-19
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2011-05-19
FWX	Table, Operating-Room, Mechanical	General, Plastic Surgery	Class 1	878.4950	2011-05-20
NZG	Bassinet, Hospital	General Hospital	Class 2	880.5145	2011-05-19
FNK	Bed, Hydraulic, Adjustable Hospital	General Hospital	Class 1	880.5110	2011-01-31
FMS	Bed, Pediatric Open Hospital	General Hospital	Class 2	880.5140	2011-05-19
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2011-05-20
FZM	Stool, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2011-05-20

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

PT. MEGA ANDALAN KALASAN

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

Similar Registrations

Registration Number	Establishment Name	Location
3030976037	CLARION CARE LLC	Valdosta, GA, US
3012316249	COMPASS HEALTH BRANDS (CORPORATE OFFICE)	Middleburg Heights, OH, US
3010785927	HENGSHUI RUNDE MEDICAL INSTRUMENTS CO.,LTD	Hengshui City Hebei, CN
3012579728	FOSHAN HUAFUKANG MEDICAL TECHNOLOGY CO. LTD	Foshan City Guangdong, CN
3014658541	SECURED ORTHO MANUFACTURING OF AMERICA, LLC	Deer Park, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008881803. Last updated year: 2026. Please use registration number 3008881803 when referencing this establishment in official correspondence.