FDA Registration
Active
🇮🇳 India
Remi Elektrotechnik Ltd.
Reg #: 3012315023
·
FEI: 3012315023
·
Expires 2026
Products
10
Proprietary Names
161
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Remi Elektrotechnik Ltd.
- Registration Number
- 3012315023
- FEI Number
- 3012315023
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Bldg B, Survey No. 65/1, Village - Valiv, Vasai (East)
- City
- Dist. Palghar Maharashtra
- Country
- IN
Owner / Operator
- Firm Name
- Remi Elektrotechnik Ltd.
- Operator Number
- 10050790
- Address
- Remi House, 11 Cama Industrial Estate, Walbhat Road,Goregaon (East)
- City
- Mumbai
- State
- IN-NOTA
- Postal Code
- 400 063
- Country
- IN
US Agent
- Business Name
- mdi Consultants, inc.
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd Ste 200
- 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 |
|---|---|---|---|---|---|
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2015-12-28 |
| Refrigerator, Freezer, Blood Storage | KSE | Class 2 | Hematology | No | 2015-12-28 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2015-12-28 |
| Tube, Collection, Capillary Blood | GIO | Class 1 | Hematology | No | 2016-10-13 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2015-12-28 |
| Freezer | JRM | Class 1 | Clinical Chemistry | No | 2015-12-28 |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | Class 1 | Hematology | No | 2015-12-28 |
| Chamber, Environmental For The Storage Of Platelet Concentrate | KSH | Class 2 | Hematology | No | 2015-12-28 |
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2015-12-28 |
| Device, Blood Mixing And Blood Weighing | KSQ | Class 1 | Hematology | No | 2015-12-28 |
Proprietary Names
Blood bag tube sealer Weldon-B,Weldon-P
Thermisafe SL, Thermisafe DL
Ultra low freezers -86 degrees C ULT-90, ULT-185, ULT-360, PDV 90 Ultra, PDV 185 Ultra, PDV 360 Ultra
Cold cabinet / Lab refrigerator: Serocool 400, Serocool 300
Plasma freezer RPFV 130, RPF 224, RPF 224 Ultra, RPF 336, RPF 336 Ultra
Blood bank refrigerator/Blood Storage Cabinet BR180Ultra, BR240, BR240Ultra, BR300, BR300Ultra,
Blood bank refrigerator/Blood storage cabinet: BR 40 SR, BR 60, BR60Ultra, BR 400, BR 500
Blood bank refrigerator/Blood Storage Cabinet BR400Ultra, BR500 Ultra, WBR80, WBR100
Cold Cabinet/Lab refrigerator RLR-200, RLR-300, RLR-400, WCR 50, WCR 80, WCR 100, WCR 120, WCR 150
Cold cabinet / Lab refrigerator CC-6 Plus, CC-10 Plus, CC-12 Plus, CC-16 Plus, CC-19 Plus, CC-28 Plus, CC-35 Plus,RLR-20
Ultra low deep freezer UDFV-90, UDFV-185, PDV 90 D, PDV 185 D
Cold Cabinet / Lab Refrigerator Refrigerator: RRF 250, RRFD 250
Ultra Low Freezers -86 Degrees C: ULT-390, ULT-490, ULT-650, PDV 390 Ultra, PDV 490 Ultra, PDV 650 Ultra
PDV 700 Ultra
BSR 200, BSR 300, BSR 400, BSR 500, BSR 700
PDV 500 Ultra
BSR 700
Refrigerated Blood Bag Working Desk: HEMODESK S, HEMODESK M, HEMODESK L
Lab Refrigerator cum freezer: HCRF 250, HCRF 250D
PDV 400 Ultra
HCDF 100 ULTRA, HCDF 200 ULTRA, HCDF 300 ULTRA, HCDF 400 ULTRA, HCDF 500 ULTRA, HCDF 700 ULTRA
PDSF 200, PDSF 300, PDSF 400, PDSF 500, PDSF 700
Cold Cabinet/Lab Refrigerator HCLR 370 Ultra, HCLR 450 Ultra, HCLR 540 Ultra, HCLR 800 Ultra, HCLR 1100 Ultra,
BSR 200
HCI 460 Ultra
HCI 460
BR-120SR
Cold Cabinet/Lab Refrigerator: HCLR 200, HCLR 280, HCLR 370, HCLR 450, HCLR 540, HCLR 800, HCLR 1100
BSR 400
Refrig... Blood Bag Working Desk Serocool E 300, Serocool E 400,Serocool 200 Ultra,Serocool 300 Ultra,Serocool 400 Ultra
Serocool 500
BR 130B
Serocool 200
HCLR 280 Ultra, HCLR 370 Ultra, HCLR 450 Ultra, HCLR 540 Ultra, HCLR 800 Ultra, HCLR 1100 Ultra, Serocool E 200
Cold Cabinet/Lab Refrigerator: HCLR 200 Ultra, HCLR 280 Ultra,
HLR 300 Ultra
HLR 200 Ultra
BR-180
HCI 200 Ultra
HCI 350
BR-120 ULTRA
BSR 300
PSF 200, PSF 300, PSF 400, PSF 500, PSF 600
BR 200B
HLR 350
PDV-100 ULTRA
BSR 500
Refrigerator, Freezer, Blood Storage, Serocool 400 Ultra
BR-50
BR 360B
BR 280B
RLR-500 Plus
BR 360B Ultra
HCI 350 Ultra
BR-50 ULTRA
HLR 460
HLR 460 Ultra
HLR 350 Ultra
BR 130B Ultra
HCI 300
PDV-200 ULTRA
BR-70SR
HCI 200
HLR 200
BR 280B Ultra
RLR-300 Plus
HCI 300 Ultra
BR-120
RLR-500
RLR-400 Plus
BR 200B Ultra
HLR 300
RLR-200 Plus
Cryopres Pro 24 IC, Cryopres Pro 48 SC, Cryopres Pro 24 SC
Cryofort UL 825, Cryofort 525D, RDF 500, ULT 825, MBT 100, MBT 60 XS, Cryopres Duo Store, Cryopres Pro 48 IC, HEMODESK,
Lab centrifuge / Micro CentrifugeR4C,R8C,RM12C,R8CBL,RM12CBL,R8M,R12M,R-10M,NEYA-8,NEYA-10,NEYA-16,RM-02Plus,RM-03Plus
Bench top centrifuge C-852, C-854/4, C-854/6, C-854/8, R-303, R-304, Medico Plus
Refrigerated centrifuge: Neya-12R
Refrigerated centrifuge C23 Plus, C24 Plus, C30 Plus CPR23 Plus, CPR24 Plus, CPR30 Plus, NEYA-10R, NEYA-16R, KPR-70Plus
Research centrifuge R 23, R 24, PR-23, PR-24
Laboratory Centrifuge / Micro Centrifuge: Neya-2, Neya-24, Neya-36, Omnicard 12c
Compact cooling centrifuge CM 8 Plus, CM 12 Plus
Laboratory Centrifuge / Micro Centrifuge: Neya-4, Neya-6, Neya-8, Neya-10, Neya-12, Neya-16, Neya-2
Refrigerated Centrifuge / Compact Cooling Centrifuge: CPR 24i Plus, Neya 24R, Neya 36R
NEYA 18R
R 8C Plus
NEYA 18
NEYA 24
R 12C Plus
Refrigerated Centrifuge: Neya-12R
RM 03 Pro, RM 02 Pro, KPR 80 Plus, KPR 90 PLus
PRP Kits for platelet concentrate: PRPgro Kit
Cooling incubator CI-6 Plus, CI-10 Plus, CI-12 Plus, CI-16 Plus, CI-19 Plus, CI-28 Plus, CI-35 Plus,CI-3S, CI-6S, CI-10S
Laboratory hot air oven: RDHO 50, RDHO 80
Thawing bath CB-704, CB-705
Orbital shaking incubator CIS-24 Plus, RIS-24 Plus
VDRL Rotator, shakers, Micro plate shaker RS-12R, VDS 300, RS-12 Plus, RS-24 BL, RS-36 BL, MPS 1, Seronn 6
Cooling Incubator CI-12S, CI-16S
Thawing bath: RWB 6
Orbital shaking incubator: CIS-18 Plus
VDRL Rotator, Shakers, Micro Plate Shaker: RSB 12, RS 24 Plus
Laboratory Hot Air Oven / Incubator: RHI 50, RHI 80, Omnicard 12i, RVO 50
CO2 Incubator: RCO-80 Plus, RCO-150 Plus
HCCI 200, HCCI 280, HCCI 370, HCCI 450, HCCI 540, HCCI 800, HCCL 1100, HCCL 200 Ultra
Cooling Incubator: HCLI 50, HCLI 80, HCLO 50, HCLO 80, HCVX 25, HCVX 25M, HCSB 12
Cooling Incubator: HCCI 370 Ultra, HCCI 450 Ultra, HCCI 540 Ultra, HCCI 800 Ultra, HCCI 1100 Ultra
HCCSI 24 Ultra, HCLI 50, HCLI 80, HCLO 50, HCLO 80, HCVX 25, HCVX 25M, HCSB 12
RDHO-130
VDS 400
RDHO-220
RHI-160
RHI-270
Cooling Incubator: HCCI 370 Ultra, HCCI 450 Ultra, HCCI 540 Ultra, HCCI 800 Ultra, HCCI 1100 Ultra, HCCSI 24 Ultra
Cooling Incubator, HCCI 200, HCCI 280, HCCI 370, HCCI 450, HCCI 540, HCCI 800, HCCI 1100, HCCI 200 Ultra, HCCI 280 Ultra
Rotator, Shakers, Micro Plate Shaker: VDS 400
SEROROLL-6
PI 10 Ultra XS, PI 10 TE, PR 10 TE, DB 10, DB 10XL, DBS 10
Thermothaw XL, Cryothaw, Cryothaw XL, CB 704 Ultra, PI 10, PR 10, PI 10 Ultra, PR 10 Ultra PR 10 Ultra XS,
HCI 200; HCI 200 Ultra; HCI 300; HCI 300 Ultra; HCI 350; HCI 350 Ultra; HCI 460; HCI 460 Ultra, Thermothaw,
RVO-50
RQV 600 Plus, RQVD 200 Plus, RQVD 300 Plus, RQVD 400 Plus, RRF 250, RRFD 250, RQFV 170, RQFV 265, RFV 245, RFV 340,
Deep freezer RQV200 Plus, RQV300 Plus, RQV400 Plus, RQV500 Plus, RQV600 Plus RQVD200 Plus, RQVD300 Plus, RQVD400 Plus
Quick freezer RQF 170, RQF 265, RQFV 170, RQFV 265, RFC-100, RFC-200, RFC-280, RFV-245, RFV-340
Deep freezer: Sero Freeze 245, Sero Freeze 340, MBT 100
Deep Freezer: RQV 600i Plus
RQF 125
RQF 240
HCLF 525 Ultra, HCLF 625 Ultra
Deep Freezer : HCLF 225, HCLF 325, HCLF 425, HCLF 525, HCLF 625, HCLF 225 Ultra, HCLF 325 Ultra, HCLF 425 Ultra
RQF 125, RQF 240, Cryofort UL 825, Cryofort 525D, MBT 100, MBT 60 XS, Cryopres Duo Store, Cryopres Pro 48 IC,
PDV 360 Ultra, PDV 390 Ultra, PDV 490 Ultra, PDV 650 Ultra; RPFV 130, RPF 224, RPF 224 Ultra, RPF 336, RPF 336 Ultra,
. ULT 90, ULT 185, ULT 360, ULT 490, ULT 650, ULT 825, RQV 200 Plus, RQV 300 Plus, RQV 400 Plus, RQV 500 Plus,
RDF 500 , PDV 100 Ultra; PDV 200 Ultra, PDV 400 Ultra; PDV 500 Ultra; PDV 700 Ultra, PDV 90 Ultra, PDV 185 Ultra,
PRP Centrifuge: PRP-41 Plus, PRP Ultra
Blood Bank centrifuge KBM 70, KBM 70 Plus, KBM 80 Plus, KBM 90 Plus
Quikfuge
CENTRIFUGE, BLOOD-BANK FOR IN VITRO DIAGNOSTIC USE: KBM 80i Plus, KBM 90i Plus,
CENTRIFUGE, BLOOD-BANK FOR IN VITRO DIAGNOSTIC USE: KBM 80 Plus LCD, KBM 80 Plus TFT
Neya 6 Plus, NEYA 18, Neya-24, Neya-36, HCM 6, HCM 15, HCR 16 Plus, HCP 7, HCP 20
PRP Plus
HCP 7C, HCP 20C, Neya 18R, Neya 24R, Neya 36R
Platelet agitator/Platelet incubator PI 10, PR 10, PI 10 Ultra, PR 10 Ultra
PI 20 Ultra, PR 20 Ultra
PR 10 Ultra, PR 10 Ultra XS, PI 10 Ultra XS, PI 10 TE, PR 10 TE
Therapeutic chair/Blood donor chair: Flabo X
Therapeutic chair/Blood donor chair Dzire 1X, Dzire 2X, Dzire 3X
Chair, Blood Donor - Therapeutic Chair/Blood Donor Chair: PDV 1X
Flabo XR
Dzire 4X
Flabo 2X, Flabo XR
PDC-1X
RDC 2M
PDC 1X
Dzire 4X, RDC 3M, RDC 3M, RDC 4M
PR 10 Ultra XS, PI 10 Ultra XS, PI 10 TE, PR 10 TE, CM 101 Plus, CM 101 Pro, CM101 Ultra, Seroroll 6, Seroroll 6 Plus,
Centrifuge bucket equalizer CBZ 50 Plus
Automated blood bag tube stripper: RQS A
Blood collection monitor BCM-10 Ultra, BCM-20 Ultra
Plasma expressor: Xpress M, Xpress A
BCM-30 Ultra, BCM-40 Ultra;
RS 12 Plus, RS 12R,RS 36 BL, RS 24Plus,RS 10 Pro, VDS 300, VDS 400, CIS 18 Plus,CIS 18 Ultra.
Establishment Types
Manufacture Medical Device