What certifications does the BM2000A have?

The device holds CE, FDA 510K, ISO13485, FCC, and RoHS certifications.

How long does the battery last?

The 3.7V lithium battery can last for more than 20 hours on a single charge.

Can I use this device for children?

Yes, it includes probes for adults, children, and neonates, suitable for different ages.

How is the data transferred to the phone?

Data is transferred via Bluetooth to the BerrySmartHealth APP for recording and reporting.

Is OEM service available?

Yes, OEM services are available with our experienced R&D team and manufacturing support.

What is the delivery time?

Standard delivery time is 7-10 days, and samples are available upon request.

Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA

Shanghai Berry Electronic Tech Co., Ltd.

13 yrs

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Product Highlights

Clinical Accuracy Validated: 98.51% accuracy in mean blood oxygen calculation with strong correlation to ECG reference.
Long Battery Life: 3.7V lithium battery lasts over 20 hours, supporting full-night sleep monitoring.
Multi-Certification: Holds CE, FDA 510K, ISO13485, FCC, and RoHS certifications for global compliance.
Smart App Integration: Connects via Bluetooth to BerrySmartHealth APP for real-time data recording and reporting.
Wide Age Applicability: Includes adult, child, and neonate probes suitable for different ages and skin colors.
OEM Customization: OEM services available with experienced R&D team and 11 years manufacturing experience.
Compact Design: Lightweight 50g device with dimensions 68x58x20mm for comfortable wear during sleep.
Rapid Delivery: Standard delivery time is 7-10 days, with samples available for testing.

Product Attributes

Customization: Available
Classification: Physiological Functions of Diagnosis and Monitoring Equipment
Type: Patient Monitor
Model NO.: BM2000A
Certification: CE, FDA, ISO13485
Group: Middle-aged and Old
Color: Blue
Experience: with 11 Years Manufacturer
R&D Department: Excellent Engineers and Technicians
Quality: ISO13485 CE TUV 0123
Delivery Time: 7-10 Days
Place of Origin: Shanghai, China (Mainland)
After-Sales: Yes
Samples: Available
OEM: Available
Applications: Hospitals, Clinics, Family
Transport Package: Box Packing
Specification: CE
Trademark: Berry
Origin: Shanghai, China
HS Code: 9018191000
Production Capacity: 5000 PCS/Month

Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA

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Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA

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Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
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Product Description

Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
BM2000A Sleep monitoring system
Suitable for sleep hypopnea syndrome monitoring

Instructions
Berry Sleep Apnea Screening Monitor has 510K, CE0123, ISO13485, FCC, RoHS and we can meet most people's measurements of blood oxygen and pulse rate. It can accurately capture pulse signals and has been validated in numerous clinical trials.

Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA
Widely Used In Daily Life
BM2000A applies to Aviation,Snorer,Child,Asthma,COPD

Major Features
1.Equipment is suitable for sleep or Apnea respiratory monitoring, especially Apnea and hypopnea monitoring.
2.Through contrast experiments with PSG, it can be used for the diagnosis of clinical sleep apnea syndrome.
3.Product is low power consumption, The 3.7V lithium battery can last for more than 20 hours.
4.The equipment has approved international CE, 510K, and other certifications.
5.Various types of sensors, which are suitable for infants and children adults and people of different ages and people of different skin colors.
6.Sleeping applet can be connected by the bluetooth. Record the data of every second actually, store and feedback the monitoring data of the whole night to the device, so as to generate the sleep report.

Operation Process
1,Download the BerrySmartHealth APP from Google Play and Apple Store.
2,Wear the equipment to keep at least 6 hours sleep monitoring.
3,Put on the device and wrap foam spO2 sensor around fingertip.
4,The collected data is transferred to the mobile phone via bluetooth.
5,Display report on phone.
6,Reports can be shared.

Technical Features

Display SpO2, PR	Battery Type: 3.7v (1000mAh) Rechargeable Lithium Batteries
Pulse Rate: Measurement range: 25 - 250bpm Accuracy: ±2bpm	SpO2: Measurement range: 35% - 100% Accuracy: ±2% (80% - 100%) ; ±3% (70% - 79%)
Size:68(L)x58(W)x20(D)mm	Weight: 50g
Working Voltage: DC 3.4v ~ DC 4.3v	Free App: "BerrySmartHealth"

Accuracy Test

Blood Oxygen Concentration Tes Pulse Rate Test

Berry Product Rate VS Reference heart rate ECG

Correlation=0.98, P-value< 0.0001

Average reference oximeter Reference Heart Rate(ECG)

Effective (SaO2) (ECG) [BPM]

Comparison: Reference Pulse Oximeter
Berry Pulse Oximeter	70 ~ 100	90 ~ 100	80 - < 90	67 - < 80	RESE≤3% Within the range of 70~100%
# pts	240	79	81	81	RESE≤3% Within the range of 70~100%
Error	-0.6	-1.1	-0.9	0.1	Pass
Root mean square error	1.9	1.7	2.0	2.1	Pass

Berry products have passed the accuracy test, blood oxygen

concentration accuracy <2%,510k requirements<3%

Parameter Comparison Chart

Apnea Trend
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA

Hypopnea Trend
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA

Software Advantage

Blood Oxygen Results Mean Blood Oxygen Results

Diagnosis Of Hypoxemia OSAHS Diagnosis

PSG vs. ROC Curve

Analysis Of Clinical Trial Results

Mean Blood Oxygen
Average blood oxygen calculation accuracy: 98.51%
Diagnosis of hypoxemia
Sensitivity: 89.29%	Specificity: 77.78%	Accuracy:92.59%
OSAHS Judgment Results
Sensitivity: 94.17%	Specificity: 61.21%	Accuracy:89.62%

Standard Configuration
1,Adult probe
2,Child probe
3,Neonate probe
4,Gift box
5,User manual

Reports can be shared.

Physical Identity
Dimension 68(H) × 58(W) × 20(D) mm
Weight About 50g (with the batteries)

Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA Company Information
Shanghai Berry Electronic Tech Co., Ltd. is located in Shanghai Caohejing High-tech Park, a beautiful low-carbon and environmentally friendly city. We have been devoted to the R&D, manufacturing and sales of medical electronic instruments in the field of monitoring since 2003.
Apnea Screening Wrist Pulse Oximeter Bm2000A with Ce and FDA Our Factory
Our Bio-Medical technology has reached the domestic advanced level. Important breakthroughs have been made in non-invasive blood pressure calculation methods, blood oxygen saturation detection, and multi-parameter monitoring systems. After years of development, we have established good cooperative relations with customers worldwide, with annual sales reaching tens of millions dollars.

About the Supplier

This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASR2541914". Items marked "" are certified.

Shanghai Berry Electronic Tech Co., Ltd.

Company Profile

Shanghai Berry Electronic Technology Co., Ltd. is located in the international city - Shanghai Caohejing High-tech Park.

Since its establishment in September 2003, Shanghai Berry Electronic Technology Co., Ltd., as an emerging high-tech medical company, has been committed to the research and development, manufacturing and sales of medical electronic instruments in the field of monitoring, focusing on product research and development and technological innovation, Looking to the future, bringing significant benefits to those who pursue a healthy life.

Our biomedical technology has reached the domestic advanced level. Important breakthroughs have been made in non-invasive blood pressure calculation methods, blood oxygen saturation detection, and multi-parameter monitoring systems. The pulse oximeter produced by the company has won the recognition of consumers for its accurate, simple and affordable features. The products are not only sold well in China, but also exported to many countries on a large scale.

Adhering to the values of "Equality, Integrity, Innovation, Excellence", we aim to provide quality products that improve their quality of life and reduce the burden on the social healthcare system. After years of development, we have established good cooperative relationships with global customers, with annual sales reaching tens of millions of dollars.

BERRY always provides customers with high-quality, cost-effective products. Maintaining good quality is important to us.

In 2009, it obtained the production license and product registration certificate issued by Shanghai.

In 2014, we passed the EN ISO 13485 quality system certification and CE0123 certification by TÜ V SÜ D. We got the 510K for wrist and handheld pulse oximeters.

In 2015, we were accredited by ANVISA, INMETRO.

In 2016, our fingertip pulse oximeter received 510K approval.

In 2018, we received CE0123 approval for patient monitors and new watch oximeters.

In 2019, Shenzhen factory was established.

Since 2022, our business has grown rapidly and has more partners.

Shanghai Berry Electronic Technology Co., Ltd., now, we are moving forward bravely and fulfilling our promise of love.

About Our Factory & Business Background

Address: Suit C, 1st Floor, 7th Building, No. 1188 Lianhang Road, Minhang District, China 201112, Shanghai, China
Terms of Payment: LC, T/T, PayPal, Western Union, Money Gram
International Commercial Terms(Incoterms): FOB, CIF, FAS, EXW
Average Lead Time: Peak Season Lead Time: one month
Off Season Lead Time: within 15 workdays
Nearest Port: shanghai, shenzhen

Our Production Capability & Technical Expertise

Main Products: SpO2 Sensor, Pulse Oximeter, Nasal Spray, Patient Monitor, OEM Patient Monitor Module, ECG&EKG Cable, NIBP &IBP, Sleep Apnea Oximeter, Veterinary Patient Monitor, Veterinary Pulse Oximeter

Our Industry Experience & Global Business Record

Export Year: 2013-01-01
Main Markets: North America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe

FAQ

What certifications does the BM2000A have?: The device holds CE, FDA 510K, ISO13485, FCC, and RoHS certifications.
How long does the battery last?: The 3.7V lithium battery can last for more than 20 hours on a single charge.
Can I use this device for children?: Yes, it includes probes for adults, children, and neonates, suitable for different ages.
How is the data transferred to the phone?: Data is transferred via Bluetooth to the BerrySmartHealth APP for recording and reporting.
Is OEM service available?: Yes, OEM services are available with our experienced R&D team and manufacturing support.
What is the delivery time?: Standard delivery time is 7-10 days, and samples are available upon request.

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