FDA Registration
Active
🇵🇱 Poland
TYRE 25x1(25-559)-IA-2255, TRAILBLAZER,510(+/- 26G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,10 PCS/BOX
Reg #: 3004945434
·
FEI: 3004945434
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Expires 2025
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
- 2025
- 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
TYRE 25x1(25-559)-IA-2255, TRAILBLAZER,510(+/- 26G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,10 PCS/BOX
TYRE 26"x1"(25-590)-IA2806S,299(+/- 15G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
PUSHRIM - D23 X 1.25 X 548 /25"/6 SPLICES SD=531MM, BLACK COVER.ALU. - DIPPED - STANDARD GRIP (65+/- SHA) (112816)
WHEEL LOCK - LOCK-P - LEFT. 90 DEGREE VERSION, PLASTIC. (SPORT BRAKE)--WITH RADIUS AND RIBS
S/A LEGREST MANUAL - RIGHT ( 22505214-002 Rev.E ) WITH GAS STRUT SM0876
FOAM COVER d18 X D34 X 660 MM, BLACK ,FOR d20 MM TUBE (HARDNESS: 18-25SHC)
QUICK-RELEASE AXLE D12 X 122 MM, STAINLESS STEEL, WITH RED POWD.COAT.ALU. RELEASE BUTTON - FOR FLANGE HUB
CASTOR WHEEL 7" SPARE SET ( 21508006 REV. B )
S/A LEGREST POWERED - LEFT ( 22505216-001 Rev.E ) WITH ACTUATOR NAT002-AX
PUSHRIM - D23 (+/-1 ) X 1.25 X 498 MM/22"/6R-PD=476 MM, 8 KNOBS, ALU COVER BY BLACK PVC PASTE ( 60-80 SHA ) ( 112824 )
SET OF ELECTRIC ACTUATOR NAQ002-C WITH MOUNTING PARTS (20010131)
WHEEL 7", D175 X 45 MM, BLACK PLASTIC RIM, 3 SPOKES /D8 X 53 MM HUB, WITH GREY POLYURETHANE TYRE
S/A LEGREST MANUAL - LEFT ( 22505214-001 Rev.E ) WITH GAS STRUT SM0876
TILT 50 deg (PM 5, P/N 20010102 REV E) (old NT0300)
Q300M BASE NA; VERSION OF 21500650 FOR TIE-DOWN BRACKET EXCESS STOCK USE ( 257332 - REV A )
S/A LEGREST FIXED, PA6-30%GF - LEFT ( 22505215-001 REV.H)
Q300M BASE ( 21500650 - REV F ) - WITH PACKING FOR USA
TYRE 20x1(25-451)-IA-2255, TRAILBLAZER,410(+/- 21G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,20 PCS/BOX
TYRE 22"x1"(25-501)-IA2806L,266(+/- 14G),SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
PUSHRIM - D23 (+/-1 ) X 1 X 556 MM/25"/6R - PD=534 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112822 )
Q300M BASE ( 21500650 - REV E ) - WITH PACKING FOR USA
PUSHRIM - NOVA H - WITH SILICONE - D536 MM / 24" / 6 SPLICES SD=515 MM, BLACK HARD ANOD ALU+ONE LOGO "OMOBIC NOVA"
TOP SHROUD; BY INJECTION MOULDED -BLACK ABS., (21514601-000 - REV B)
PUSHRIM-D23 X 1 X 582 /26"/6 SPLICES SD=564MM, BLACK COVER.ALU-ULTRA HIGH FRICTION-MEDIUM GRIP (60-80 SHA) (112817)
PUSHRIM - D22 X 1 X 492 /22"/ 6 SPLICES SD=472 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
TYRE 22x1(25-501)-IA-2255L, TRAILBLAZER,456(+/- 23G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING,20 PCS/BOX
PUSHRIM - D22 X 1 X 552 /25"/ 6 SPLICES SD=532 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
TYRE 25x1"(25-559)-IA2806S,279(+/- 14G), SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
PUSHRIM - D23 (+/-1 ) X 1.25 X 449 MM/20"/6R - PD=426 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112819 )
PUSHRIM - D23 (+/-1 ) X 1.25 X 499 MM/22"/6R - PD=476 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112820 )
SET OF ELECTRIC ACTUATOR NAQ002-C WITH MOUNTING PARTS AND SWICTH HOLDER
TYRE 20"x1"(25-451)-IA2806M,245(+/- 13G),SPEEDLITE, FULL BLACK, BK/BSK+PTR+67TPI+ 2 LOGOS,NON-MARKING
TILT 50 deg (PM 4, P/N 20010101, Rev E)
SEAT INTERFACE COMPLETE - LH - Q300M MINI ( 21500652-001 - REV F )
S/A LEGREST POWERED - RIGHT ( 22505216-002 Rev.E ) WITH ACTUATOR NAT002-AX
TYRE 26x1(25-590)-IA-2255, TRAILBLAZER,536(+/- 27G),FULL BLACK, BK+PTR(3.5MM)+67TPI+ 2 LOGOS,NON-MARKING
WHEEL 8", D200 X 50 MM, D8 X 53 MM HUB, BLACK PLAST RIM 3 SPOKES WITH GREY TYRE/TUBE
PUSHRIM-D23 X 1 X 441 /20"/6 SPLICES SD=421 MM, BLACK COVER.ALU-ULTRA HIGH FRICTION-MEDIUM GRIP ( 60-80 SHA)
TYRE 24"X1"(25-540)-TRAILBLAZER, IA-2255,490(+/-25G), FULL BLACK, BK+PTR(3.5MM)+67TPI + 2 LOGOS, NON-MARKING,12 PCS/BOX
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
SET OF 95101DC2 WITH MOUNTING BOLTS (20010132)
QUICK-RELEASE AXLE D1/2" X 104 MM, STAINLESS STEEL WITH BLACK TETRA HANDLE (ROUND TYPE)
PUSHRIM - D22 X 1 X 532 /24"/ 6 SPLICES SD=512 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
PUSHRIM - D23 (+/-1 ) X 1.25 X 537 MM/24"/6R-PD=515 MM, 8 KNOBS, ALU COVER BY BLACK PVC PASTE ( 60-80 SHA ) ( 112825 )
PUSHRIM - D23 (+/-1 ) X 1.25 X 587 MM/26"/6R - PD=565 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112823 )
WHEEL LOCK - LOCK-P - RIGHT. 90 DEGREE VERSION, PLASTIC, (SPORT BRAKE).--WITH RADIUS AND RIBS
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
SEAT INTERFACE COMPLETE - RH - Q300M MINI ( 21500652-002 - REV F )
S/A LEGREST FIXED, PA6-30%GF - RIGHT ( 22505215-002 REV.H)
PUSHRIM - D23 (+/-1 ) X 1.25 X 537 MM/24"/6R - PD=515 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112821 )
PUSHRIM-D23 X 1.25 X 543 /24"/6 SPLICES SD=523MM, BLACK COVER.ALU-ULTRA HIGH FRICTION-MEDIUM GRIP ( 60-80 SHA) (112812 )
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 X 1 X 532 /24"/6 SPLICES SD=512MM, BLACK COVER.ALU-ULTRA HIGH FRICTION-MEDIUM GRIP ( 60-80 SHA) (112815)
PUSHRIM - D23 (+/-1 ) X 1 X 398 MM/18"/3R - PD=375 MM, ALU COVERED WITH BLACK PVC PASTE ( 60-80 SHA ) ( 112818 )
BAG WITH 500 CLIPS FOR FITTING OF SPOKE SHIELD
TYRE 24" X 1" ( 25-540 ) - SPEEDLITE, IA-2806S,266(+/- 14G), FULL BLACK, BK/BSK+PTR+67TPI + 2 LOGOS, NON-MARKING
PUSHRIM - D22 X 1 X 583 /26"/ 6 SPLICES SD=563 / ALU. COVERED WITH BLACK MORE STICKY PASTE 65+/-5 SHA
Establishment Types
Manufacture Medical Device