FDA Registration
Active
🇮🇩 Indonesia
PT. MEGA ANDALAN KALASAN
Reg #: 3008881803
·
FEI: 3008881803
·
Expires 2026
Products
17
Proprietary Names
112
Establishment Types
1
Classifications
17
Registration Details
- Registration Name
- PT. MEGA ANDALAN KALASAN
- Registration Number
- 3008881803
- FEI Number
- 3008881803
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- JL. TANJUNG TIRTOMARTANI, KALASAN KM 13
- City
- JOGYAKARTA Yogyakarta
- Country
- ID
Owner / Operator
- Firm Name
- PT. MEGA ANDALAN KALASAN
- Operator Number
- 10035069
- Address
- RASUNA OFFICE PARK, SUITE SO-02, KOMP EPICENTRUM JL. HR RASUNA SAID
- City
- JAKARTA
- State
- ID-JK
- Postal Code
- 12960
- Country
- ID
US Agent
- Business Name
- mdi Consultants, Inc
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2011-05-20 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2011-05-19 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2011-05-19 |
| Chair, Examination And Treatment | FRK | Class 1 | General Hospital | No | 2011-05-19 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2011-05-19 |
| Table, Operating-Room, Mechanical | FWX | Class 1 | General, Plastic Surgery | No | 2011-05-20 |
| Bassinet, Hospital | NZG | Class 2 | General Hospital | No | 2011-05-19 |
| Bed, Hydraulic, Adjustable Hospital | FNK | Class 1 | General Hospital | No | 2011-01-31 |
| Bed, Pediatric Open Hospital | FMS | Class 2 | General Hospital | No | 2011-05-19 |
| Table, Examination, Medical, Powered | LGX | Class 1 | General, Plastic Surgery | No | 2011-05-20 |
| Stool, Operating-Room | FZM | Class 1 | General, Plastic Surgery | No | 2011-05-20 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2011-05-20 |
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2011-01-31 |
| Chair And Table, Medical | KMN | Class 1 | General Hospital | No | 2011-05-13 |
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2011-05-19 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2011-05-20 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2011-05-12 |
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
35114 Mayo Stand; MT701 Operating Table Accessory Trolley; MT302 Food Trolley; 31811 Bedside Cabinet
36607 Anaesthesia Cart; 36608 Medicine Cart; 36609 Emergency Cart; 31812 Overbed Table, Lock Pin Type
73031 Overbed Table Gasspring Type; 73073 Andalas Overbed Table *73173; 73073M Andalas Overbed Table *73173M
MT502 Emergency Trolley 36604 Anaesthesia Trolley; 36605 Medical Report Trolley; 36606 Emergency Cart;
MT201 Dressing Trolley; MT301 Food Trolley; 35301 Laundry Trolley; 35102 Dressing Trolley; 35103 Mayo Stand
32902 Medicine Cabinet; 32903 Medicine Cabinet; MB101 Instrument Trolley; 35101 Instrument Trolley
36601 Medicine Trolley; 36602 50 Drawer Medicine Trolley; 36603A Emergency Trolley; 30603 Emergency Trolley
32515 Locker 12 Cupboards; 32921 Drugs Cabinet 32923; Weekly Storage Cabinet 6
MT611 Clean Washing Trolley; MT612 Clean Washing Trolley; MT601 Dirty Washing Trolley; MT501 Emergency Trolley
Bedside Cabinet 31811, 31814, 31815, 31816, 31817, 31824, 33031, 33032, 33132, 73032, 77091; 32901 Instrument Cabinet
73033 Overbed Table; 77071 Overbed Table; MA103 Overbed Table; MA113 Overbed Table
31824 Bedside Cabinet 73132 Bedside Cabinet; 73172 Bedside Cabinet; 33132 Bedside Cabinet; 32911 Instrument Cabinet;
MT401 Medicine Trolley; 20 MT402 Medicine Trolley 40; 36617 Anesthesia Cart; 36619 Emergency Cart; 35113 Mayo Stand
32912 Medicine Cabinet; 32913 Medicine Cabinet; MC102 Bedside Cabinet; 32514 Locker 6 Cupboards
MA102 Overbed Table MA101 Overbed Table; 35111 Instrument Trolley; 35112 Dressing Trolley; MT101 Instrument Trolley
73005 Manual Supramak Bed -Centrallock castor; 77001 Manual Crank Sotamak Bed; 73052 Andalas Bed (2 cranks)
MB224 MAK Borneo Manual Bed 3 Cranks CLC; 74001 Manual Celebes Bed - 1 crank (side blow)
74012 Manual Celebes Bed - 2 cranks (side rail); 74013 Manual Celebes Bed - 3 cranks (side rail)
73007 Manual Supramak Bed -Backrest + Kneerest; 73010 Manual Supramak Bed -Stainless Steel Sideguard
MB511 Moluccas Bed 1 Crank; MB512 Moluccas Bed 2 Cranks; MB513 Moluccas Bed 3 Cranks
MB501 MAK Mollucas Bed - 1 crank; MB502 MAK Mollucas Bed - 2 cranks; MB521 MAK Mollucas Junior Bed - 1 crank
74002 Manual Celebes Bed - 2 cranks (side blow); 74003 Manual Celebes Bed - 3 cranks (side blow)
75014 Manual Lovina Bed - 3 cranks (side rail-central lock); 99001 Folding Bed; 74104 Celebes Bed 3 Crank SB, CLC
MB222 MAK Borneo Manual Bed 2 Cranks; MB223 MAK Borneo Manual Bed 3 Cranks
MB552 Manual Mollucas Bed - 2 cranks (With castor); MB551 Manual Mollucas Bed - 1 crank (With castor)
33104 Classic Bed Backrest Type, w/out sideguard, steel panel; 33105 Classic Bed Backrest Type, w/sideguard, steel panel
MB522 MAK Mollucas Junior Bed - 2 cranks; MB201 MAK Borneo Manual Bed 1 Crank
75004 Manual Lovina Bed - 3 cranks (side blow-central lock); 75011 Manual Lovina Bed - 1 crank (side rail)
73064 La Nina Bed (3 cranks CLC); 73063 La Nina Bed (3 cranks ); 73062 La Nina Bed (2 cranks )
75002 Manual Lovina Bed - 2 cranks (side blow); 75003 Manual Lovina Bed - 3 cranks (side blow)
73061 , La Nina Bed (1 crank); MB531 Manual Mollucas Bed - 1 crank (With castor)
MM101 Mattress Latex; MM202 Mattress Foam; MM204 Mattress Foam; MM201 Mattress Foam; 36112 Room Divider 2 Sheets
73053 , Andalas Bed (3 cranks); 73054 Andalas Bed (3 cranks CLC); 73051 Andalas Bed (1 crank)
33102 Classic Bed Backrest Type, without sideguard, wood panel; 33103 Classic Bed Backrest Type, w/sideguard, wood panel
MB204 MAK Borneo Manual Bed 3 Cranks CLC; MB211 MAK Borneo Jr. Manual Bed 1 Crank
73004 Manual Supramak Bed -5'' Swivel castor; 73006 Manual Supramak Bed -Backrest + Kneerest
MB212 MAK Borneo Jr. Manual Bed 2 Cranks; MB213 MAK Borneo Jr. Manual Bed 3 Cranks
MB411 Manual Lovina Bed 1 Crank
MB214 MAK Borneo Jr. Manual Bed 3 Crank CLC; MB221 MAK Borneo Manual Bed 1 Crank
MB532 Manual Mollucas Bed - 2 cranks (With castor); MB553 Manual Mollucas Bed - 3 cranks (With castor)
36203 Room Divider 3 Sheets; MA104 Dining Table; MM203 Mattress Foam Adult
33106 Classic Bed Fowler Type, without sideguard, wood panel; 33107 Classic Bed Fowler Type, w/sideguard, wood panel
74004 Manual Celebes Bed - 3 cranks (side blow-central lock); 74011 Manual Celebes Bed - 1 crank (side rail)
MB414 Manual Lovina Bed 3 Crank, CLC; MB413 Manual Lovina Bed 3 Crank; MB412 Manual Lovina Bed 2 Crank
MB202 MAK Borneo Manual Bed 2 Cranks; MB203 MAK Borneo Manual Bed 3 Cranks
75012 Manual Lovina Bed - 2 cranks (side rail); 75013 Manual Lovina Bed - 3 cranks (side rail)
74014 Manual Celebes Bed - 3 cranks (side rail-central lock); 75001 Manual Lovina Bed - 1 crank (side blow)
MB433 Manual Lovina Bed 3 Cranks; MB432 Manual Lovina Bed 2 Cranks; MB431 Manual Lovina Bed 1 Cranks
ME112 L `De Table; 34101 Examination Table; 34105 Examination Table; 34112 Gynecolog Exami Table, Mild Steel
34112 Gynecolog Examination Table, Mild Steel; ME101 Examination Table (knockdown system); ME111 Examination Table
Gynecolog Examination Table, Stainless Steel 34102, 34103, 34109, 34117 34102K; Gynecolog Exam table, knockdown system
31306 Blood Donor Chair; 31307 Drip Chair
MO221 Electro-Hydraulic Operating Table; MO222 Electro-Hydraulic Operating Table (Sliding) 4
52501 E Electric Operating Table *52512E; 52502 E Electric Operating Table with gasspring; MO213 Electric Operating Tab.
MA401 Orthopedic Traction Set; MA402 Ophtalmology Head Support
Long Single, 2 Functions Adjustable Bed - Long Queen; King Single, 2 Functions Adjustable Bed - King Single
Queen, 4 Functions Adjustable Bed - Long Queen; Long Single, 3 Functions Adjustable Bed - Long Single
77022 Electric Sotamak Bed with CPR; 77031 Electric Sotamak Bed with trendelenburg and nurse control
Long Single, OVAL BED - Long Single; 34191 Electric Delivery Bed, 3 Motors; MB105 Titanium Bed 3 Motors
MB225 MAK Borneo Bed 3 Motors; Long Single, 4 Functions Adjustable Bed - Long Single
77051 Electric Sotamak Bed with trendelenburg, keypad sideguard and nurse control
75006 Electric Celebes Bed - Lovina Bed MB205 MAK Borneo Bed 3 Motors; MB215 MAK Borneo Jr. Bed 3 Motors;
36112 Room Divider 2 Sheets; 36203 Room Divider 3 Sheets
74007 ICU Electric Celebes Bed 5 Motors; 74006W Electric Celebes Bed 4 Motors WS;74005W Electric Cebeles Bed 3 Motors WS
73001 Electric Supramak Bed; 73002 Electric Supramak Bed Centrallock Castor
77032 Electric Sotamak Bed with trendelenburg, nurse control and CPR; 73055 Electric Andalas Bed
MB446 Electric Lovina Bed 4 Motor;s MB445 Electric Lovina Bed 3 Motors; MB305 Electric Andalas Bed 3 Motors
King Single, 3 Functions Adjustable Bed - King Single; Half Queen, 2 Functions Adjustable Bed - Half Queen
79003 Electric Infinite Bed-3 Motors; 74005 Electric Celebes Bed; 74006 Electric Celebes Bed; 75005 Electric Celebes Bed
77041 Electric Sotamak Bed with keypad sideguard; 77042 Electric Sotamak Bed with keypad sideguard and CPR
77052 Electric Sotamak Bed with trendelenburg, keypad sideguard, nurse control and CPR
Electric ICU-ICCU Supramak Bed 73003 (73003 W, 73003 CPR, 73003 WCPR); 77021 Electric Sotamak Bed
79103W Electric Infinite 3 Motors WS; 74008 ICU Electric Celebes Bed 6 Motors;74008 ICU Electric Celebes Bed 6 Motors WS
81005 Borneo Bed 81006 Iborneo Bed; 79001 Electric Infinite Bed-4 Motors; 79002 Electric Infinite Bed-5 Motors
King Single, 4 Functions Adjustable Bed - King Single; Long Double, 4 Functions Adjustable Bed - Long Double
MB106 Titanium Bed 4 Motors; 81003A Electric Satomak Bed; 79101W Electric Infinite 4 Motors WS
73065 Electric La Nina Bed; 77032 Electric Sotamak Bed with trendelenburg, nurse control and CPR
MM101 Mattress Latex; MM202 Mattress Foam; MM204 Mattress Foam; MM201 Mattress Foam; MM203 Mattress Foam Adult
74106 Celebes Electric Bed 4 Motors, SB, CLC; 74105 Celebes Electric Bed 3 Motors, SB CLC
78001 Electric ICU-ICCU Sotamak Bed with Column; 81003 Electric Satomak Bed; 81004 Electric Satomak Bed
Establishment Types
Manufacture Medical Device