FDA Registration
Active
🇨🇳 China
Shenzhen Caremed Medical Technology Co.,Ltd.
Reg #: 3011713222
·
FEI: 3011713222
·
Expires 2026
Products
8
Proprietary Names
129
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Shenzhen Caremed Medical Technology Co.,Ltd.
- Registration Number
- 3011713222
- FEI Number
- 3011713222
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road, Gaofeng Community, Dalang office, Longhua District, Shenzhen
- City
- shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K191279
Owner / Operator
- Firm Name
- Shenzhen Caremed Medical Technology Co.,Ltd.
- Operator Number
- 10049378
- Address
- 3/F, Building C, Xiazao Digital Industrial Park, No. 8 Huali Road, Gaofeng Community,Dalang Office,Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2015-05-22 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2021-12-28 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2018-09-25 |
| Binder, Abdominal | FSD | Class 1 | General Hospital | No | 2015-05-22 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2020-05-07 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2016-11-23 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-21 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2019-10-29 |
Proprietary Names
Caremed Reusable Temperature Probe
Caremed Disposable Temperature Probe
C503-16
C533-16
C543-16
C523-16
C503-01
C503-49
853030005
H8-CF103
H8-CF101
Disposable ECG cable
KM-82080
Caremed Diaposable Abdominal belt
Caremed resuable Abdominal belt
Dispoable face mask
SA30S-91
Caremed compatible oximeter sensors,Caremed Reusable & Disposable SpO2 Sensors
C803-01X
SA10B-127
SA30B-02
C410B-15R
SA30B-21
C410B-153R
SA30B-07
C803-49R
SA36B-15R
SA30B-29
C403B-49R
SA30B-20
SA15B-91
SA10B-08
C410-21X
SA30B-48R
SA20B-91
C103F-49R
SA30B-21R
SA30B-75
SA30B-43X
SA10B-01
SA30B-48
SA30B-09
C403S-49R
C903-91
SA30B-91
SA20B-08
C403S-15
SA15B-49R
SA30B-08
SA10B-75
C403B-117
C403-01
C403B-01X
SA30B-300
SA36B-15*
C430B-146D
SA30B-01X
SA30C-01X
SA30Y-01X
N543-01
SA36B-15
2585P
E10R-SH1-N
MQ-2586
Caremed Patient Cable and Leadwires for ECG,EKG,SpO2 and Blood Pressure Monitors
ED5R-90S-A
EK10R-SH1-PA
KM-82096
KM-PA01048B
KM-PA01048G
KM-PA01048R
LSI-ECGL40
LSI-ECGL30
KM-PA01060G
LSI-ECGL24
KM-PA02036G
KM-82060/E
KM-PA050540RG
KM-PA051348TC
KM-82060
MQ10-LN
E10R-MQ
KM-PA01060R
MQB5-90S
TRCS-2252
TRCG-2252
Temperature probe
TRAS-2252
TRAG-2252
Face mask
N1C-TS
N1N1-TS
N1N2-TD
N1N-PS
N1I-PD
N1N5-TD
N1AL-TS
N1C-PD
N1LL-TS
N1AL-PS
N1A-PD
N1AL-PD
N1N5-TS
N1I-PS
N1A-TD
N1T-PD
N1N3-TD
N1N4-TS
N1N2-TS
N1S-TD
N1L-TS
N1AL-TD
N1A-PS
N1C-PS
Blood Pressure cuffs
N1C-TD
N1S-TS
N1L-TD
N1I-TD
N1T-PS
N1S-PS
N1S-PD
N1N4-TD
N1L-PD
N1N1-TD
N1N-PD
N1A-TS
N1I-TS
N1LL-TD
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device