FDA Registration
Active
🇩🇴 Dominican Republic
AccuMed Corp.
Reg #: 3007309299
·
FEI: 3007309299
·
Expires 2026
Products
19
Proprietary Names
110
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- AccuMed Corp.
- Registration Number
- 3007309299
- FEI Number
- 3007309299
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Carretera Sanchez KM 20, Zona Franca de Nigua
- City
- Nigua San Cristobal
- Country
- DO
Owner / Operator
- Firm Name
- AccuMed Corp
- Operator Number
- 10040676
- Address
- Parque Industrial Itabo KM 18 1/2, Antigua Carretera Sanchez, Building 10 Haina
- City
- San Cristobal
- State
- DO-21
- Postal Code
- 91000
- Country
- DO
- Correspondent
- Zoila Jimenez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2009-02-19 |
| Bed, Flotation Therapy, Powered | IOQ | Class 2 | Physical Medicine | No | 2014-03-11 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2011-01-20 |
| Hood, Surgical | FXY | Class 2 | General, Plastic Surgery | No | 2021-06-09 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2018-02-02 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2011-09-21 |
| Orthosis, Lumbo-Sacral | IPY | Class 1 | Physical Medicine | No | 2011-01-04 |
| Cushion, Flotation | KIC | Class 1 | Physical Medicine | No | 2020-09-01 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2020-09-01 |
| Mattress, Flotation Therapy, Non-Powered | IKY | Class 1 | General Hospital | No | 2018-07-11 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2015-09-24 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2020-10-23 |
| Splint, Clavicle | IQJ | Class 1 | Physical Medicine | No | 2009-02-19 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2011-08-21 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2020-09-01 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2011-01-04 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2009-09-11 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2010-04-26 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2017-02-07 |
Proprietary Names
Bone Growth Extension Strap
Lateral Air Mattress
DEVICE, TRANSFER, PATIENT, MANUAL
T7 Hood with Peel Away Face Shield
T7 Hood with Anti-Reflective Face Shield
T7Plus Hood with Peel Away Face Shield
T7Plus Hood with Anti-Reflective Face Shield
pd belt
System, monitoring, perinatal
Disposable abdominal belt M2208A
DISPOSABLE HIGH II, SIZE M/L
DISP HIGH BARIATRIC XXL/XXXL
DISP HIGH BARIATRIC, SIZE XL/XXL
DISP HIGH BARIATRIC, SIZE LXL
DISPOSABLE LEG SLING II
DISPOSABLE HIGH II, SIZE L/XL
DISPOSABLE REPOSITION SLING
DISPOSABLE TWIN TURNER II LG
DISPOSABLE HIGH II SIZE XL/XXL
DISPOSABLE HIGH II, KIDS 6-10
DISPOSABLE TWIN TURNER II REG
DISPOSABLE HORIZONTAL SLING
DISPOSABLE HIGH II, SIZE XS/S
DISPOSABLE HIGH II, SIZE S/M
Lift, patient, non-ac-powered
TPOD Trauma PElvic Orthotic Device
ORTHOSIS, LUMBO-SACRAL
MATTRESS, FLOTATION THERAPY, NON-POWERED
MDT821203 Gait Belt
Single Patient Use Wraps
TOURNIQUET, NONPNEUMATIC
E-Mat Emergency Tourniquet
Puresom Classic
HEADGEAR ESON SMALL
GENERIC HEADGEAR, STANDARD
LSM HEADGEAR - EASYLIFE
ESON2 HEADGEAR ASSEMBLY ML
FITLIFE 1.5 LARGE HEADGEAR S/A
RP RS EASYLIFE HDGR., TS
DREAMWEAR HEADGEAR
NUANCE HEADGEAR, RP
Tube Wrap
Puresom premier
RESPIREO SOFT BABY HEADGEAR XS
AF421 L/XL HEADGEAR
Puresom Ultra
Headgear RP Kit
KANGAROO HEADGEAR, FOLDED
AF541 S/M CAPSTRAP HDG
Puresom Nasal Pillow
ESON2 HEADGEAR ASSEMBLY S
HEADSTRAP ONE
HEADGEAR CPAP 401
Puresom Ruby Adjustable
AMARA RS HDGR ASSY W/ CLIP
AF541 L/XL CAP STRAP HDG
SU FACE MASK HEADGEAR W/CROWN
RP PICO RS HEADGEAR
CHROME HEADGEAR
Puresom Ruby, Large
AMARA HDGR ASSY W/ CLIP
RP TRUEBLUE HEADGEAR
RP EASYLIFE HDGR., TS
DREAMWEAR HEADGEAR, RP
ASSY, WRIST STRAP
HEADGEAR SIMPLUS SMALL
Puresom Ruby Adjustable XL
RP AMARA HEADGEAR
FITLIFE 1.5 XL HEADGEAR S/A
HEADSTRAP 3, SEWED
HC452 STRAP
RP-AMARA VIEW HDGR., STD.
FITLIFE 1.5 SMALL HEADGEAR S/A
ASSY, WRIST STRAP, LONG
HEADGEAR SIMPLUS MEDIUM/LARGE
RP-AMARA VIEW HDGR., LARGE
TRUEBLUE HEADGEAR WRAPPED S/A
RP PICO HEADGEAR
AF541 L/XL 4-POINT CROWN HDG
CLINIC HEADSTRAP
Puresom Ruby, Medium
KANGAROO LONG FABRIC FRAME
Puresom secure
RESPIREO SOFT BABY HEADGEAR S
RP-RS AMARA HEADGEAR
RP RS TRUEBLUE HEADGEAR
Puresom Ultra Plus
HEADGEAR ESON LARGE
Puresom Ruby, Small
KANGAROO HEADGEAR
Headgear
Puresom Universal
PILAIRO Q HEADGEAR
PREMIUM CHIN STRAP
AMARA VIEW HDGR., STD.
HEADSTRAP EASYFIT LITE
HEADGEAR HC406
GENERIC HEADGEAR, LARGE
AF421 S/M HEADGEAR
HEADGEAR JOYCE LITE
VITERA
DISPOSABLE CONTOUR HEADSTRAP
WISP, STANDARD HDGR., FOLDED
RESPIREO PRIMO P HEADGEAR
AF541 S/M 4-POINT CROWN HDG
BREVIDA HEADGEAR ASSEMBLY
STRAP, HEAD, GAS MASK
Juxtalite
BINDER, MEDICAL, THERAPEUTIC
HOVER MATT TRANSFER TECHNOLOGY, Hovermatt single patient use
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)