EU Manufacturer
๐จ๐ณ China
Active
Biomedical Instruments Co., Ltd.
SRN: CN-MF-000016483
ยท
Room 4C1, F2.6 Tianzhan building, Tianan Chegongmiao Industrial Zone, Futian District., 518042 Shenzhen, China
Basic UDI-DIs
13
Total Devices
22
On Market
21
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
6
Basic Information
- Address
- Room 4C1, F2.6 Tianzhan building, Tianan Chegongmiao Industrial Zone, Futian District., 518042 Shenzhen, China
- [email protected]
- Phone
- +86-755-83733866
- Website
- www.bi-biomed.com
Regulatory Overview
Regulation
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Eu Mdd
10
Eu Mdr
3
Classification
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Eu Md Class 2a
13
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | G2 18 01 64548 017 | TรV SรD Product Service GmbH | Mar 31, 2023 |
Market Presence
Devices from this manufacturer are available in 6 countries across Europe.
๐ง๐ฌ Bulgaria
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ต๐ฑ Poland
๐ต๐น Portugal
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| BLOOD PRESSURE HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| BLOOD PRESSURE HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDR | Eu Md Class 2a | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDR | Eu Md Class 2a | On Market | 0 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDR | Eu Md Class 2a | On Market | 0 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDR | Eu Md Class 2a | On Market | 0 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES | EU MDD | Eu Md Class 2a | On Market | 1 |
| NONโINVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES | EU MDR | Eu Md Class 2a | Off Market | 0 |