FDA Registration
Active
🇩🇪 Germany
CNSAC MEDSHOP GMBH
Reg #: 3014236293
·
FEI: 3014236293
·
Expires 2026
Products
5
Proprietary Names
46
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CNSAC MEDSHOP GMBH
- Registration Number
- 3014236293
- FEI Number
- 3014236293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Biebelrieder Str 42
- City
- Theilheim Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K212325
Owner / Operator
- Firm Name
- CNSAC MedShop GmbH
- Operator Number
- 10088631
- Address
- Biebelrieder Str 42
- City
- Theilheim
- State
- Bavaria
- Postal Code
- 97288
- Country
- DE
- Correspondent
- Arash Kianian
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-12-23 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2025-12-23 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2023-12-26 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2023-09-08 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2025-12-23 |
Proprietary Names
DE-242 CNSAC ECG Electrode, Offset, Foam, 35 x 56 mm
DE-220-CNSAC ECG Electrode, Foam, 30 mm round
DE-241 CNSAC ECG Electrode, Offset, Foam, 35 x 50 mm
SEN004 (revB) Disposable ECG Electrode, drop shape, 43 x 49 mm, non-woven (fleece)
DE-008c-CNSAC Disposable Electrode (ECG and PLM), 2,8 x 4,5 cm
DE-009c-CNSAC Disposable Electrode Doublepatch (Intercostal EMG, ECG and PLM recordings), Size 3,5 x 5,5 cm
DE-244 CNSAC TAB Electrode, Solid gel, 23 x 34 mm
DE-245 (SEN020) CNSAC Pre-Wired Electrode for Infants, 60 cm cable length, Non-woven, 22 x 22 mm
DE-221CNSAC ECG Electrode, Foam, 50 mm round
DE-233 CNSAC ECG Electrode, Crescent shape, Foam, 24 x 39 mm
DE-231 (SEN004)-CNSAC ECG Electrode, Drop shape, Non-woven, 43 x 49 mm
DE-237 CNSAC ECG Electrode, Radiolucent, Bottle shape, Foam, 35 x 56 mm
DE-232 CNSAC ECG Electrode, Drop shape, Foam, 43 x 49 mm
DE_230CNSAC ECG Electrode, Drop shape, Non-woven, 30 x 36 mm
SEN020 (revB) Disposable Pre-Wired Electrode for infants, 22 x 22 mm, non-woven
DE-234 CNSAC ECG Electrode, Bottle shape, Foam, 35 x 56 mm
HC-155 CPAP filter for ResMed AirSense 11
HC-162: Hypoallergenic CPAP filters for Loewenstein prismaLINE
HC-151 Hypoallergenic CPAP filters for ResMed AirSens S9 & S10
HC-160: CPAP filters for Loewenstein prismaLINE
HC-150 CPAP filter for ResMed AirSens S9 & S10 CPAP devices,
HC-161: Air filter for Loewenstein prismaLINE
HC-156 Hypoallergenic CPAP filters for ResMed AirSens 11
CNSAC Nasal Cannula, adults, 210 cm (83?) tubing with (female) Luer-Lock connector
CNSAC Nasal/Oral Cannula for Pediatric (from 1 year on), 180 cm tubing, with (male) Luer-Lock connector
CNSAC CPAP adapter including 80 cm (31'') PVC tube, 100 pcs., with (male) Luer-Lock connector
CNSAC Nasal Cannula including filter connector compatible with NOX, 60 cm (24) tubing
CNSAC Nasal Cannula, adults, 30 cm (12?) tubing with (male) Luer-Lock connector
CNSAC Nasal Cannula for Pediatric (from 1 year on), with (male) Luer-Lock connector
CNSAC Nasal Cannula, adults, 60 cm (24?) tubing with (female) Luer-Lock connector
CNSAC Nasal/Oral Cannula for Pressure Sensor, 180 cm (71?) tubing with (male) Luer-Lock connector
CNSAC Nasal/Oral Cannula for Pressure Sensor, 60 cm (24?) tubing with (male) Luer-Lock connector
CNSAC Nasal Cannula, adults, 150 cm (60?) tubing with (male) Luer-Lock connector
CPAP adapter including 200 cm (78'') PVC tube, 100 pcs., with (male) Luer-Lock connector
CNSAC Nasal Cannula for Newborn (up to 10 months), with (male) Luer-Lock connector
CNSAC NasalOxy nasal cannula for O2 supply, 210 cm (83'')Tubing
CNSAC Nasal Cannula, adults, 210 cm (83?) tubing with (male) Luer-Lock connector
SEN117 (rev B) Nasal Cannula for Newborn (up to 10 months), 210 cm (83") tubing, (male) Luer-Lock connector
SEN125 (Rev B) Nasal/Oral Cannula, pediatric, 180 cm (71') tubing, (male) Luer-Lock connector
CNSAC Nasal Cannula, adults, 60 cm (24?) tubing with (male) Luer-Lock connector
SEN116B (Rev B) Nasal Cannula for Pediatric (from 1 year on), 40 cm (16") tubing, (male) Luer-Lock connector
SEN115 (Rev B) Nasal Cannula for Dynamic Pressure Measurement, 60 cm (24") tubing, (male) Luer-Lock connector
SEN116 (Rev B) Nasal Cannula for Pediatric (from 1 year on), 210 cm (83") tubing, (male) Luer-Lock connector
EEG-acp paste
EC2+US
LP300 LifePipe® PORTABLE RESPIRATORY THERAPY DEVICE, 3x LifePipes and 1x strap
Establishment Types
Manufacture Medical Device