FDA Registration
Active
🇵🇱 Poland
MBL POLAND SP. Z O.O.
Reg #: 3004945434
·
FEI: 3004945434
·
Expires 2026
Products
1
Proprietary Names
57
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MBL POLAND SP. Z O.O.
- Registration Number
- 3004945434
- FEI Number
- 3004945434
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ul. Sulejowska 45D
- City
- Piotrkow Trybunalski Lodzkie
- Country
- PL
Owner / Operator
- Firm Name
- MBL Poland sp. z o.o.
- Operator Number
- 10057802
- Address
- ul. Sulejowska 45 D
- City
- Piotrkow Trybunalski
- State
- Lodzkie
- Postal Code
- 97-300
- Country
- PL
- Correspondent
- Karolina Szubska
US Agent
- Business Name
- MBLNA LLC
- Contact Name
- Doug Barbacci
- Address
- 58 Pittston Ave
- City
- Pittston
- State
- PA
- ZIP
- 18640
- Country
- US
- [email protected]
- Phone
- 570 6023141
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Components, Wheelchair | KNN | Class 1 | Physical Medicine | No | 2018-05-29 |
Proprietary Names
PUSHRIM - D23 (+/-1 ) X 1 X 556/25"/6R-PD=534, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112822 )
TILT 50 deg (PM 4, P/N 20010101 Rev J)
PUSHRIM - D23 X 1 X 398/18"/3R - PD=375, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112818 )
PUSHRIM - D23 X 1.25 X 537/24"/6R-PD=515, 8 KNOBS, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112825 )
TOP SHROUD; BY INJECTION MOULDED -BLACK ABS., (21514601-000 - REV B)
SET OF ELECTRIC ACTUATOR NAQ002-C WITH MOUNTING PARTS (20010131)
Pneumatic tyre OMOBIC SPEEDLITE 20'', black non-marking, etrto 25-451, IA2806 pattern
PUSHRIM - D22 X 1 X 532 /24"/ 6 SPLICES SD=512 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
Pneumatic tyre OMOBIC TRAIBLAZER 20'', black non-marking, etrto 25-451, IA-2255 pattern
PUSHRIM-D23 X 1.25 X 543/24"/6 SPLICES SD=523, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA) (112812 )
PUSHRIM - D23 (+/-1 ) X 1.25 X 499/22"/6R-PD=476, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112820 )
CASTOR WHEEL 7" SPARE SET ( 21508006 REV. B )
PUSHRIM-D23 X 1 X 532 /24"/6 SPLICES SD=512, ALU+THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA) (112815)
TYRE OMOBIC GAZELLE 24'', D23-540, BLACK NON MARKING, IA-2321
QUICK-RELEASE AXLE D1/2" X 104 MM, STAINLESS STEEL WITH BLACK TETRA HANDLE (ROUND TYPE)
LIFT 160KG / 300MM /, LIMIT/INDI, (PM 8, P/N 20010305 REV F) SWL 215kg
TETRA HANDLE FOR QR-AXLE, M12 X 1 X D20 X 24 MM, L - 59.5 MM, BLACK ANOD. ALUMINIUM (ROUND TYPE)
S/A LEGREST FIXED, PA6-30%GF - RIGHT ( 22505215-002 REV.I )
FRONT FORK H 180 X W 53 MM, D 27 MM X 20 DG X T 9 MM, BLACK ANODIZED ALU.WITH d12.7 TOP HOLE AND 5 X d8.2 MM HOLES
PUSHRIM - D23 (+/-1 ) X 1.25 X 537/24"/6R-PD=515, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112821 )
Pushrim 25", 531 mm fitting distance, aluminium with thin layer of black PVC paste, with 6 splices
TYRE 26x1(25-590)-IA-2255, TRAILBLAZER,536(+/- 27G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING
PUSHRIM - D19.6 X 1.25 X 506 MM/24"/6 BENT SPLICES-PD 523 MM,BLACK POWDER COATED ALU.WITH 9 SOFT ALU.KNOBS
DAYLITE WHEEL - 24", BL DW ALU.RIM INCL.6 X M5 RVN.+?1/2"X48/70 BL ALU.RAD. HUB, 24 SUPER-LIGHT SPOKES/BL - RADIAL-R
QUICK-RELEASE AXLE D12 X 122 MM, STAINLESS STEEL, WITH RED POWD.COAT.ALU. RELEASE BUTTON - FOR FLANGE HUB
TILT & CAM LIFT 220KG / 300MM / 50DEG, INCHIBIT & SENSOR (SFE PM 10, P/N 20010250 rev G)
TYRE 25x1(25-559)-IA-2255, TRAILBLAZER,510(+/- 26G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,10 PCS/BOX
PUSHRIM - D22 X 1 X 583 /26"/ 6 SPLICES SD=563 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
ELECTRIC ACTUATOR, 6000N, BID 263-267/100 MM, 24V, 2-PIN MOLEX 900MM, 270 DEGREE, W/O E-BRAKE; MOT136738
S/A LEGREST MANUAL - LEFT ( 22505214-001 Rev.E ) WITH GAS STRUT SM0876
PUSHRIM - D19.6 X 1.25 X 555 MM/26"/6 BENT SPLICES-PD 573 MM,BLACK POWDER COATED ALU.WITH 9 SOFT ALU.KNOBS
WHEEL LOCK - LOCK-P - LEFT. 90 DEGREE VERSION, PLASTIC. (SPORT BRAKE)--WITH RADIUS AND RIBS
Pneumatic tyre OMOBIC TRAIBLAZER 24'', black non-marking, etrto 25-540 IA-2255 pattern
S/A LEGREST FIXED, PA6-30%GF - LEFT ( 22505215-001 REV.I )
Q300M BASE ( 21500650 - REV F ) - WITH PACKING FOR USA
TYRE 26"x1"(25-590)-IA2806S,299(+/- 15G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
FOAM COVER d18 X D34 X 660 MM, BLACK ,FOR d20 MM TUBE (HARDNESS: 18-25SHC)
TYRE 24" X 1 3/8", 37-540, INNOVA, BLACK, 1175#,BLOCK PATTERNED, 450KPA, IA-2803, 65PSI, 450kPa,NON-MARKING
PUSHRIM-D23 X 1 X 582 /26"/6 SPLICES SD=564, ALU+THIN LAYER OF BLACK PVC PASTE (60-80 SHA) (112817)
SET OF 95101DC2 WITH MOUNTING BOLTS (20010132)
PUSHRIM-D23 X 1.25 X 498/22"/6R-PD=476, 8 KNOBS, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112824 )
WHEEL 8", D200 X 50 MM, D8 X 53 MM HUB, BLACK PLAST RIM 3 SPOKES WITH GREY TYRE/TUBE
Pneumatic tyre OMOBIC SPEEDLITE 22'', black non-marking, etrto 25-501, IA2806 pattern
DAYLITE WHEEL - 25", BL DW ALU.RIM INCL.6 X M5 RVN.+D1/2"X48/70 BL ALU.RADIAL HUB, 24 SUPER-LIGHT SPOKES/BL - RADIAL
Pneumatic tyre OMOBIC SPEEDLITE 24'', black non-marking, etrto 25-540, IA2806 pattern
TYRE 25x1"(25-559)-IA2806S,279(+/- 14G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
BAG WITH 500 CLIPS FOR FITTING OF SPOKE SHIELD
MINI QUICK-RELEASE AXLE D10 X 35 MM, WITH WIRE AND 2 PCS RING, STAINLESS STEEL
WHEEL 7", D175 X 45 MM, BLACK PLASTIC RIM, 3 SPOKES /D8 X 53 MM HUB, WITH GREY POLYURETHANE TYRE
PUSHRIM - D22 X 1 X 552 /25"/ 6 SPLICES SD=532 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
Pneumatic tyre OMOBIC TRAIBLAZER 22'', black non-marking, etrto 25-501, IA-2255 pattern
PUSHRIM - D22 X 1 X 492 /22"/ 6 SPLICES SD=472 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
PUSHRIM - D23 (+/-1 ) X 1.25 X 449/20"/6R-PD=426, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112819 )
WHEEL LOCK - LOCK-P - RIGHT. 90 DEGREE VERSION, PLASTIC, (SPORT BRAKE).--WITH RADIUS AND RIBS
Pushrim OMOBIC NOVA H 24", 515 mm fitting distance, black hard anodized aluminium, with 6 splices
S/A LEGREST MANUAL - RIGHT ( 22505214-002 Rev.E ) WITH GAS STRUT SM0876
PUSHRIM - D23 (+/-1 ) X 1.25 X 587/26"/6R-PD=565, ALU + THIN LAYER OF BLACK PVC PASTE ( 60-80 SHA ) ( 112823 )
Establishment Types
Manufacture Medical Device